Biomarker Procalcitonin Offered Limited Benefit Over Clinical Judgement In Antibiotic Prescribing Patterns

MedicalResearch.com Interview with:

David T. Huang, MD, MPH Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science Director, MACRO (Multidisciplinary Acute Care Research Organization) Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness) University of Pittsburgh

Dr. David Huang

David T. Huang, MD, MPH
Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science
Director, MACRO (Multidisciplinary Acute Care Research Organization)
Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness)
University of Pittsburgh

MedicalResearch.com: What is the background for this study?

Response: The overuse of antibiotics has become a serious threat to global public health, causing antibiotic resistance and increasing health care costs. Physicians have long known that antibiotics are usually unnecessary for acute bronchitis and for some other cases of lower respiratory tract infections, and that antibiotics treat only bacterial infections, not viral. But in daily practice, many physicians often prescribe them.

Previous research had reported that using a biomarker blood test and following an antibiotic guideline tied to the test results could reduce antibiotic use in lower respiratory tract infections. In February 2017, the U.S. Food and Drug Administration approved the biomarker test that measures procalcitonin – a peptide that typically increases in bacterial infections, but not viral.

We conducted the Procalcitonin Antibiotic Consensus Trial (ProACT) trial to evaluate whether a procalcitonin antibiotic prescribing guideline, implemented for the treatment of suspected lower respiratory tract infection with reproducible strategies, would result in less exposure to antibiotics than usual care, without a significantly higher rate of adverse events.

The ProACT trial involved 14 predominately urban academic hospitals. We enrolled 1,656 adult patients who presented to the hospital emergency department and were initially diagnosed with a lower respiratory tract infection. All the patients were tested for their procalcitonin levels, but the results were shared only with the physicians of the patients randomly assigned to procalcitonin-guided antibiotic prescription.

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Trial of Antibody Immunotherapy in Parkinson’s Disease

MedicalResearch.com Interview with:

Joseph Jankovic, MD Professor of Neurology  Distinguished Chair in Movement Disorders  Director, Parkinson’s Disease Center  and Movement Disorders Clinic  Department of Neurology                                    Baylor College of Medicine  Baylor St. Luke’s Medical Center at the McNair Campus Houston, TX 77030-4202

Dr. Jankovic

Joseph Jankovic, MD
Professor of Neurology
Distinguished Chair in Movement Disorders
Director, Parkinson’s Disease Center
and Movement Disorders Clinic
Department of Neurology
Baylor College of Medicine
Baylor St. Luke’s Medical Center at the McNair Campus
Houston, TX 77030-4202

 

MedicalResearch.com: What should readers take away from your study? 

  • First demonstration of an anti-α-synuclein antibody immunotherapy in patients with Parkinson’s Disease.
  • Robust target engagement led to mean reduction of up to 97% in serum free α-synuclein levels.
  • Central Nervous System penetration is supported by a dose-dependent increase in PRX002/RG7935 levels in Cerebral Spinal Fluid.
  • All dose levels of PRX002/RG7935 had acceptable safety and tolerability profiles, meeting the primary objective of this study
  • Data support ongoing PASADENA Phase 2 clinical study of PRX002/RG7935 (NCT03100149)  

Citation:

Jankovic J, Goodman I, Safirstein B, et al. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti–α-Synuclein Monoclonal Antibody, in Patients With Parkinson DiseaseA Randomized Clinical TrialJAMA Neurol. Published online June 18, 2018. doi:10.1001/jamaneurol.2018.1487 

 

 

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Fewer Re-infarctions With hs Troponin To Assess Heart Attacks

MedicalResearch.com Interview with:

Martin J Holzmann MD, PhD

Dr. Holzmann

Martin J Holzmann MD, PhD
Functional Area of Emergency Medicine
Department of Internal Medicine,
Solna, Karolinska Institutet
Stockholm, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We wanted to investigate how the introduction of the new high-sensitivity cardiac troponin T (hs-cTnT) assay affected incidence of myocardial infarction (MI) use of coronary angiography, cardiac revascularizations, and prognosis in patients with myocardial infarction.

We found that the incidence of MI increased by approximately 5%, with no change in mortality, but with an 11% reduced risk of reinfarctions, and a small increase in coronary angiographies, and cardiac revascularizations by 16%, and 13%, respectively.  Continue reading

Synovial tissue profiling in autoantibody positive at risk individuals reveals gene signatures associated with later development of rheumatoid arthritis

MedicalResearch.com Interview with:

Dr. Lisa van Baarsen PhD Principal Investigator at the Amsterdam Rheumatology and Immunology Cente Academic Medical Center the Netherlands.

Dr. van Baarsen

Dr. Lisa van Baarsen PhD
Principal Investigator at the Amsterdam Rheumatology and Immunology Cente
Academic Medical Center
the Netherlands 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The discovery that autoantibodies can be present years before the onset of clinical symptoms of rheumatoid arthritis (RA) enables us to study autoantibody positive individuals who are at risk of developing RA. In patients with established disease the target tissue of RA, the synovial joints, is characterized by cellular infiltration and inflammation. Moreover, successful therapy decreases this synovial inflammation. In the past, our department already showed (PMID: 21177292; PMID: 24574210) that in autoantibody positive at risk individuals there is no overt cellular infiltration present in the synovium.

In the current study we performed a so called discovery-based approach to investigate at a genome-wide gene expression level (using microarrays) whether the synovium is altered at a molecular level before onset of rheumatoid arthritis.

Our molecular and microscopic studies on synovial biopsies obtained from autoantibody positive individuals indeed revealed interesting differences between those at risk individuals who developed disease after follow up and those who did not. Continue reading

PDL1 Amplification Linked To Positive Response to Checkpoint Blockers

MedicalResearch.com Interview with

Aaron Goodman, MD Hematologist/Medical Oncologist Assistant Professor of Medicine UC San Diego Health

Dr. Goodman

Aaron Goodman, MD
Hematologist/Medical Oncologist
Assistant Professor of Medicine
UC San Diego Health 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Response rates to PD-1/PD-L1 blockade in solid tumors are reported at 10-20%.  Remarkably, response rates of 65% to 87% have been reported in patients with refractory classical Hodgkin lymphoma treated with checkpoint inhibitors.

In nodular sclerosing Hodgkin lymphoma, amplification of the chromosomal region 9p24.1, which contains the genes PD-L1 (CD274)PDCD1LG2 (PD-L2)and JAK2, is directly correlated with increased expression of these proteins on Reed–Sternberg cells.

Overall, 105 of 108 (97%) biopsies from patients with newly diagnosed classical Hodgkin lymphoma have increased PD-L1 and PDCD1LG2 copy numbers.  The prevalence and utility of PD-L1amplification as a response biomarker to PD-1/PD-L1 blockade is unknown in other tumors.

We sought to determine the prevalence and utility of PD-L1 amplification as a response biomarker to PD-1/PD-L1 blockade in solid tumors.  Continue reading

New Test Can Identify Asthma With Nasal Brush Biomarker

MedicalResearch.com Interview with:
Dr. Supinda Bunyavanich MD

Pediatric Allergy and Immunology
Physician and researcher at the Icahn School of Medicine.

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: In this study, we report on an accurate asthma biomarker we have developed based on a simple nasal brush.

Nasal Brush-based Classifier of Asthma

Asthma is a chronic respiratory disease that affects 10% of children and adults in the U.S. Mild to moderate asthma can be difficult to diagnose because symptoms change over time and can be complicated by other respiratory conditions. Given the high prevalence of asthma, there is high potential impact of improved diagnostic tools on reducing morbidity and mortality from asthma.

Current diagnostic tools for asthma, including spirometry and bronchoscopy, require specialized equipment and expertise to operate properly. Many individuals, particularly young children, have difficulty with pulmonary function testing because it requires, coordinated, forced breaths into a device. Spirometry results are unreliable when done with poor technique. Bronchoscopy is not practical for mild to moderate symptoms. For these reasons, asthma is often diagnosed and managed based on self-reporting of symptoms  This can be unreliable, resulting in repeated doctor visits and even trips to the ER. Thus, a biomarker test for asthma that is easy to implement and interpret is highly desirable for the diagnosis and management of asthma. Continue reading

Urinary Biomarkers Identify Early Problems With Hip Replacements

MedicalResearch.com Interview with:

Rick Sumner, PhD, FAAA The Mary Lou Bell McGrew Presidential Professor for Medical Research Chair, Department of Cell & Molecular Medicine (formerly, Anatomy and Cell Biology) Rush University Medical Center Chicago, IL  60612

Dr. Sumner

Rick Sumner, PhD, FAAA
The Mary Lou Bell McGrew Presidential Professor for Medical Research
Chair, Department of Cell & Molecular Medicine (formerly, Anatomy and Cell Biology)
Rush University Medical Center
Chicago, IL  60612

 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The main cause of failure for total hip replacements is implant loosening which is often a consequence of particle-induced peri-implant osteolysis. Unfortunately, this condition is usually not diagnosed until it has progressed to the point of needing a revision surgery.

We discovered two biomarkers that may be useful for identifying at risk patients much earlier than is currently possible. Continue reading

What Happened to Prostate Cancer Screening and Treatment After PSA Guidelines Changed?

MedicalResearch.com Interview with:

James T. Kearns, MD Clinical Fellow, Department of Urology University of Washington School of Medicine Seattle, WA 

Dr. Kearns

James T. Kearns, MD
Clinical Fellow, Department of Urology
University of Washington School of Medicine
Seattle, WA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The effects of the USPSTF recommendation against prostate cancer screening had not been fully characterized among a younger population, particularly with respect to downstream effects such as prostate biopsy, prostate cancer diagnosis, and treatment for prostate cancer.

We found that PSA testing decreased in the years surrounding the USPSTF recommendation, but we also found a larger proportionate decrease in prostate biopsy, prostate cancer diagnosis, and use of surgery or radiation for the treatment of prostate cancer.

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PlaqueTec Liquid Biopsies Give Alternative Data To Systemic Biomarkers

MedicalResearch.com Interview with:
PlaqueTec liquid biopsiesDr. Nick West, MD
PlaqueTec Chief Medical Officer and Consultant Interventional Cardiologist
Royal Papworth Hospital NHS Foundation Trust  

MedicalResearch.com: What is the background for this study?

Response: Recent data have identified residual inflammatory risk as a potential therapeutic target to modulate future risk of coronary and vascular events independent of cholesterol lowering1. This approach has now been validated by the CANTOS study, showing reduction of peripheral blood levels of high-sensitivity CRP (hsCRP) and consequent reduction of the occurrence of major cardiac events in patients who had sustained a myocardial infarction2,3. Although controversy continues to rage regarding the relevance of ‘vulnerable plaque’ versus ‘vulnerable patient’ in the causation of acute coronary events, evolving data suggest a complex interplay between a proinflammatory milieu and ‘vulnerable’ plaque phenotypes 4,5 .

We used a novel dedicated intracoronary sampling catheter, the PlaqueTec Liquid Biopsy SystemTM (LBS), and sought to correlate systemic inflammatory indices with degree of local coronary inflammatory activity. The LBS has previously been validated to safely delineate the presence of gradients of inflammatory biomolecules in human coronary artery disease6. We measured blood levels of a large panel of inflammatory biomolecules using multiplexed assays in peripheral blood and in coronary-derived blood samples after balloon dilatation of coronary stenoses during coronary angioplasty, and assessed systemic levels of hsCRP by ELISA.

MedicalResearch.com: What are the main findings? 

Response: Statistical analysis using K-means indicated our patient population (n=23), predominantly patients with stable angina, segregated into 2 discrete clusters of high and low overall coronary inflammatory states. However, when compared with peripheral (systemic) levels of the same inflammatory biomolecules in each cluster, there was no meaningful relationship. Additionally, there was no difference between median hsCRP measurements between the 2 clusters. Taken together, these data suggest that simply measuring peripheral markers of inflammation may not be able to determine local inflammatory activity within the coronary artery itself. 

MedicalResearch.com: What should readers take away from your report?
What recommendations do you have for future research as a result of this work?

Response: These data provide interesting and hypothesis-generating data that explore the mechanisms of benefit in vascular risk by reducing systemic inflammation; rather than hsCRP acting as a simple ‘barometer’ for likelihood of events, it appears that presence of coronary inflammation may be an independent entity. Further studies are needed to address the complex relationship between systemic and coronary inflammation, and their respective interaction with ‘vulnerable’ plaque phenotypes in modulating patient events.

Disclosures: Dr West acts as a consultant to, and holds equity in, PlaqueTec Ltd.

Citations:

  1. Ridker PM. Residual inflammatory risk: addressing the obverse side of the atherosclerosis prevention coin. Eur Heart J 2016; 37: 1720-22.
  2. Ridker PM, Everett BM, Thuren T et al. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med 2017; 377: 1119-31.
  3. Ridker PM, MacFadyen JG, Everett BM et al. Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomissed controlled trial. Lancet 2018; 391: 319-28.
  4. Libby P, Pasterkamp G. Requiem for the vulnerable plaque. Eur Heart J 2015; 36: 2984-7.
  5. Hansson GK, Libby P, Tabas I. Inflammation and plaque vulnerability. J Intern Med 2015; 278: 483-93.
  6. West NEJ, Corrigan JP, Owen RHG et al. Percutaneous sampling of local biomolecule gradients across coronary artery atherosclerotic plaques. J Am Coll Cardiol Basic Trans Science 2017; 2: 646-54.

Citation:

PlaqueTec Data Presented at EAS Show Lack of Correlation 
between Localised Coronary Artery Inflammatory Biomarker Expression and Systemic Elevation of Biomarkers including hsCRP

 

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Amyloid Biomarker Predictive of Mortality in Non-STEMI Heart Attack

MedicalResearch.com Interview with:

Prof. Dr. med. Konstantinos Stellos,MD, FAHA, FESC Cardiovascular Research Centre, Institute of Genetic Medicine Newcastle upon Tyne United Kingdom

Prof. Stellos

Prof. Dr. med. Konstantinos Stellos,MD, FAHA, FESC
Cardiovascular Research Centre, Institute of Genetic Medicine
Newcastle upon Tyne
United Kingdom

MedicalResearch.com: What is the background for this study?

 

Response: Risk stratification of patients with a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains a major challenge in clinical cardiology. Risk stratification is important to identify patients at high risk, to whom an early coronary intervention with optimal adjunctive medical therapy shall be applied to reduce that risk. Conversely, it is equally important to identify patients at low risk, to whom a potentially hazardous invasive therapy or a multi-drug administration shall be avoided. Current ACC/AHA and ESC guidelines agree in a standardized approach that uses Global Registry of Acute Coronary Events (GRACE) score, a well validated scoring system, to calculate a patient’s risk and guide triage and management decisions.

Amyloid-β (Aβ) 1-40 and 1-42 peptides (Aβ40 and Aβ42), are proteolytic fragments of a larger protein, the amyloid precursor protein (APP) cleaved by β- and γ-secretases, found in typical brain amyloid deposits in Alzheimer’s disease. Many lines of evidence support a role of Aβ40 in cardiovascular disease as a peptide with pro-inflammatory and pro-thrombotic properties. Most cardiovascular risk factors seem to affect APP metabolism and thus, Aβ production and its soluble circulating APP770 isoform are elevated in patients with ACS_ENREF_15, suggesting a role for Aβ40 in the triggering and outcome of ACS in stable CAD patients. Although vascular inflammation is considered as a hallmark in the pathophysiologic pathways of coronary artery disease (CAD) and novel mechanisms are continuously recognized in its pathogenesis, no inflammatory marker is currently recommended for risk stratification of patients with NSTE-ACS individually or as a component of the GRACE score. This may partly explain the moderate discriminative ability of GRACE score in some studies, especially in older patients and those after early percutaneous coronary intervention (PCI).

In this retrospective study, we used data from two independent prospective cohorts, the Heidelberg study (n=1,145) and the validation multicenter international APACE (Advantageous Predictors of Acute Coronary Syndrome Evaluation, n=734) study and determined the clinical prognostic and reclassification value of baseline circulating Aβ40 levels in the prediction of mortality over the GRACE risk score in patients with NSTE-ACS across a median follow-up of 21.9 ( Heidelberg cohort) and 24.9 months (APACE cohort), respectively.

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Can a Pill Plus Infrared Light Replace Mammograms?

MedicalResearch.com Interview with:

Greg Thurber, PhD Assistant Professor Department of Chemical Engineering Assistant Professor Department of Biomedical Engineering University of Michigan 

Dr. Thurber

Greg Thurber, PhD
Assistant Professor
Department of Chemical Engineering
Assistant Professor
Department of Biomedical Engineering
University of Michigan 

MedicalResearch.com: What is the background for this study?

Response: Most current disease screening strategies rely on either blood tests, where the physician can obtain information on specific disease molecules but has no idea where they originated in the body, or anatomical imaging, where the physician can see changes in the structure of tissues but doesn’t have any molecular information. We wanted to develop a method that could provide both molecular information and an image of where these molecules were located. We know from decades of research in cancer that this is a molecular disease, so providing molecular information to the physician will help improve detection and diagnosis. Breast cancer screening provides an excellent opportunity to apply this approach to improve detection. Currently, estimates indicate that we are overspending $4 billion per year on the overdiagnosis and overtreatment of breast cancer because we cannot accurately determine which patients need treatment and which can be safely monitored with no intervention. Despite this problem with overdiagnosis, however, screening saves lives…we simply need a better way.

Molecular imaging has the capability of providing both molecular information and the location within the body. However, most of these techniques are expensive and use ionizing radiation, meaning there is a small risk of actually causing cancer. This is not acceptable for screening large numbers of otherwise healthy patients. To avoid this risk and provide a safe, inexpensive, and relatively easy method for patients to undergo screening, we decided to develop near-infrared fluorescent imaging agents that can be taken as a pill. The goal is for the patient to simply take a pill a day or two before their visit, and then the physician shines near-infrared light on the breast tissue to detect tumors where they ‘light up’ by giving off a different color of light.

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Sciatica: Biomarker Demonstrates Inflammation, Not Just Compression of Nerve Roots

MedicalResearch.com Interview with:

“osteopathic treatment for sciatica” by betterhealthosteopathy is licensed under PDM 3.0Daniel Albrecht, PhD
Research Fellow in Radiology, Harvard Medical School
Research Fellow, Massachusetts General Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A great deal of preclinical work in animal models of pain has established that activation of peripheral immune cells or, in the central nervous system (brain and spinal cord), immune cells called “glia” (microglia and astrocytes) play a key role in the establishment and/or maintenance of persistent pain. For instance, if you pharmacologically block activation of these cells in the nervous system, you are able to reduce/inhibit/prevent pain behaviors, e.g. in animals who have received a nerve injury.

This observation is very exciting, because it suggests that blocking neuroinflammation may be a viable way of treating pain. However, the evidence linking human chronic pain with neuroinflammation has so far been limited.

In this study we show, for the first time, that patients with chronic sciatica (that is, back pain that shoots down the leg) demonstrate elevations in the levels of a protein called the translocator protein (TSPO) in the spinal cord and in the nerve roots.

Because TSPO is a marker of neuroinflammation, our results suggest that sciatica is associated with neuroinflammation.

While on average patients do show elevations in the levels of the TSPO, we also saw significant variability across individuals. Importantly, patients that show stronger elevations (in the nerve roots) were those who benefit the most from receiving a local anti-inflammatory treatment (epidural spinal injection). This makes sense: patients whose nerve roots are inflamed benefit from an anti-inflammatory treatment. Those whose nerve roots aren’t inflamed, don’t receive the same benefit. In the latter case, the source of the inflammation and pain may not be the nerve roots, but may be the spinal cord, or, as we showed in a previous paper (Loggia et al., Brain 2015), the brain.  Continue reading

Specific Types of Inflammation Tied to Cardiovascular Disease

MedicalResearch.com Interview with:

Dr. Karl T. Kelsey, MD, MOH Professor of Epidemiology and Pathology and Laboratory Medicine Fellow, Collegium Ramazzini Providence, R.I. 02912

Dr. Kelsey

Dr. Karl T. Kelsey, MD, MOH
Professor of Epidemiology and Pathology and Laboratory Medicine
Fellow, Collegium Ramazzini
Providence, R.I. 02912

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: ​There is a large literature suggesting that the ratio of neutrophils to lymphocytes (the neutrophil to lymphocyte ratio or NLR) in the peripheral blood at the time of diagnosis is robustly predictive ​of outcome in acute cardiovascular disease.

We were curious to know if the peripheral blood profile and this ratio was a feature of the disease process, since, to our knowledge, this had not been investigated in a prospective study.  Hence, we used the resources of 2 prospective studies to assess this question, the Jackson Heart Study and the Normative Aging Study.  In both cases, the NLR predicted all cause mortality and, in the Jackson Heart Study, where we had well adjudicated outcomes, the NLR predicted various specific cardiovascular outcomes as well. Interestingly, the outcome was also modified by a well known genetic polymorphism of African origin that results in a relative neutropenia.

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Liquid Biopsy Can Guide Radiation Therapy in Early Stage Breast Cancer

MedicalResearch.com Interview with:

Chelain Goodman, MD PhD PGY-3, Radiation Oncology Northwestern University Chicago, IL 60611

Dr. Goodman

Chelain Goodman, MD PhD
PGY-3, Radiation Oncology
Northwestern University
Chicago, IL 60611

MedicalResearch.com: What is the background for this study?

Response: Circulating tumor cells are cancer cells that are shed from the primary tumor into the peripheral blood stream and are hypothesized to be one of the first steps in the initiation of metastatic progression. Prospective studies have demonstrated that approximately 15-25% of patients with early-stage breast cancer can be found to have at least one circulating tumor cell in a small sample of their blood. Currently, all patients with early-stage invasive breast cancer who undergo breast conserving surgery receive adjuvant radiation therapy. In these analyses, we wanted to determine whether presence of circulating tumor cells may be predictive of benefit of radiation therapy following surgery.

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RNA-based Blood Test Can Detect Fibromyalgia

MedicalResearch.com interview with:

Dr. Chase Spurlock, PhD CEO, IQuity, Specialty Diagnostic Technologies Faculty, Vanderbilt University Medical Center

Dr. Chase Spurlock

Dr. Chase Spurlock, PhD
CEO, 
IQuitySpecialty Diagnostic Technologies
Faculty, Vanderbilt University Medical Center

Dr. Spurlock discusses IQuity’s release of IsolateFibromyalgia, the first RNA-based blood test to detect fibromyalgia.

MedicalResearch.com: What is the background for this test? Would you briefly explain what fibromyalgia is, whom it affects and why it has been difficult to definitely diagnosis? 

Dr. Spurlock: We developed the IsolateFibromyalgia™ test using our established RNA assay platform, IQIsolate™, to help clinicians receive timely and accurate information. This technology has evolved from over a decade of research at Vanderbilt University and continues at IQuity funded by both the National Institutes of Health (NIH) as well as private investors. We discovered that differences in RNA expression patterns could be detected in patients with a variety of human conditions spanning infection to more complex inflammatory diseases. With our focus on autoimmune disease, we identified and validated RNAs capable of distinguishing multiple sclerosis, IBS, Crohn’s, ulcerative colitis and fibromyalgia syndrome. In the case of fibromyalgia, our research involved almost 600 subjects including healthy individuals, patients with endocrine conditions, dermatologic conditions and rheumatologic diseases — rheumatoid arthritis, Sjogren’s syndrome and systemic lupus erythematosus. Reported sensitivity and specificity of this assay is 92 percent and 96 percent, respectively.

Fibromyalgia syndrome is characterized by widespread musculoskeletal pain often initially localized to the neck and shoulders. Patients typically describe pain throughout the muscles but may also report pain in the joints. Furthermore, fibromyalgia is usually accompanied by fatigue as well as cognitive disturbance. Patients most afflicted are women between ages 20 and 55. Fibromyalgia affects approximately as many as 6-10 million people in the U.S.

The difficulty in reaching a definitive diagnosis lies in two important issues. First, the cause of the syndrome is unknown, and the way the condition presents and progresses can vary among patients. Secondarily, fibromyalgia syndrome mimics many other conditions due to the multiple nonspecific symptoms associated with fibromyalgia. Patients look well, there are no obvious abnormalities on physical examination other than tenderness, and laboratory and radiologic studies are normal. With no discernable abnormalities in routine clinical laboratory testing or imaging, the diagnosis is based on subjective reporting of symptoms.

The difficulties and complex nature of receiving a correct fibromyalgia diagnosis are apparent. Despite improved awareness among primary care clinicians, many continue to be uncomfortable with making this diagnosis. Fibromyalgia patients on average wait almost a year after experiencing symptoms before seeing a physician and end up visiting on average 3.7 different physicians before a diagnosis. The diagnostic journey can take years. IsolateFibromyalgia provides the clinician and patient actionable information with 94 percent accuracy.

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Low-Intensity PSA-Based Screening Does Not Reduce Prostate Cancer Deaths

MedicalResearch.com Interview with:

Richard Martin Professor of Clinical Epidemiology Head of Section, Clinical Epidemiology & Public Health Population Health Sciences Bristol Medical School 

Prof. Martin

Richard Martin
Professor of Clinical Epidemiology
Head of Section, Clinical Epidemiology & Public Health
Population Health Sciences
Bristol Medical School 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Screening for prostate cancer using the PSA test aims to detect prostate cancer at an early stage, before symptoms develop, when treatment can be offered that may avoid the risks of advanced cancer or may extend life.

Evidence from a large European trial suggests that PSA screening at 2 to 4 yearly intervals could reduce prostate-cancer deaths by 20%. after 13 years of follow-up. However, there are problems with the accuracy of the PSA test and potential harmful consequences. In particular, using the PSA test to screen for prostate cancer results in some tested men being diagnosed with low-risk, harmless cancers that are unlikely to progress or require treatment.  This problem may be particularly exacerbated when using repeated PSA testing as a screening strategy.

The CAP trial offered a one-off PSA test to men aged 50-69 years in the UK. The goal of this low-intensity, one-off PSA testing was to avoid unnecessary screening while still identifying men with high risk, aggressive cancers for whom screening and early detection can reduce morbidity and mortality. However, we found that after an average 10-years of follow-up, the PSA test still detected too many low-risk prostate cancers, while also missing cancers that did need treatment. After an average 10-years of follow-up, the group who had been screened had the same percentage of men dying from prostate cancer as those who had not been screened (0.29%).  Continue reading

Autoantibodies Generated By Zika Virus May Explain Some Consequences of Infection

MedicalResearch.com Interview with:

Slobodan Paessler, D.V.M., Ph.D. Associate Professor, Department of Pathology; Director, Galveston National Laboratory Preclinical Studies Core;  Director, Animal Biosafety Level 3, Institute for Human Infections and Immunity; Member, Center for Biodefense & Emerging Infectious Diseases University of Texas Medical Branch  Galveston, TX

Dr. Paessler

Slobodan Paessler, D.V.M., Ph.D.
Professor, Department of Pathology;
Director, Galveston National Laboratory Preclinical Studies Core;
Director, Animal Biosafety Level 3, Institute for Human Infections and Immunity;
Member, Center for Biodefense & Emerging Infectious Diseases
University of Texas Medical Branch
Galveston, TX

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Zika virus infection is associated with various developmental issues for human embryos such as reduced head growth, reduced brain tissue growth, and damage to brain or eyes. We wanted to better understand if some of these birth defects are caused directly by the Zika virus or maybe by the host response to infection.

In our study we demonstrate that the Zika virus infection induces autoimmune response against the C1q protein. This protein is a very important immune protein as well as one of the essential proteins for healthy brain development. Attacking the C1q protein upon exposure with the Zika virus could contribute to the development of autoimmune disorders and birth defects.  Continue reading

Genetic Variant of p53 Associated With Poor Breast Cancer Survival

MedicalResearch.com Interview with:
Maureen E. Murphy, Ph.D.
Program Leader and Professor
Molecular and Cellular Oncogenesis and
Subhasree Basu PhD
Postdoctoral researcher
The Wistar Institute
Philadelphia, PA 19104

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Unlike most other genes that are intimately involved in the cause of cancer, the p53 gene displays considerable genetic variation; in other words, p53 is unusual among cancer genes in that the amino acids in p53 protein can frequently differ amongst different populations and ethnic groups. Additionally, unlike most other tumor suppressor genes, when p53 is mutated in a tumor, as it is in 50% of human cancers, that mutant protein now has a positive function in cancer progression, changing tumor metabolism and promoting tumor metastasis.

In this study, the authors analyze for the first time the impact of a common genetic variant in p53 (single nucleotide polymorphism, or SNP) in the ability of mutant p53 to promote tumor metabolism and metastasis, and they find significant differences.  Continue reading

CTC Blood Test Can Reduce Unnecessary Prostate Biopsies in PSA ‘Gray-Zone’

MedicalResearch.com Interview with:
https://cellmaxlife.com/Atul Sharan
Co-Founder & CEO at CellMax 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Approximately 30 million men in the United States take the Prostate-Specific Antigen (PSA) screening test. Recent studies published in the Annals of Internal Medicine have established that PSA screenings have resulted in reduced mortality from prostate cancer. However, the problem with the PSA test is that many patients will receive indeterminate results. Only one in five of patients who have taken the test will have a positive biopsy for prostate cancer, but 33 percent of these patients could suffer from biopsy related side effects, and 1 percent will require hospitalization.

This study showed that the CellMax CTC blood test can predict which patients in the gray zone will need/have a positive prostate biopsy with a much lower false positive rate than current standard of care tests, potentially reducing unnecessary biopsies in this group by up to 90 percent. At the same time, the sensitivity of this test at 80 percent was comparable to the current standard of care tests, meaning this test was also accurate in ruling out biopsy in patients. 

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Adding Blood Biomarker To Ultrasound Improves Liver Cancer Detection

MedicalResearch.com Interview with:

Amit Singal MD MS David Bruton Jr. Professor in Clinical Cancer Research Associate Professor of Medicine Medical Director of Liver Tumor Program Clinical Chief of Hepatology University of Texas Southwestern

Dr. Amit Singal

Amit Singal MD MS
David Bruton Jr. Professor in Clinical Cancer Research
Associate Professor of Medicine
Medical Director of Liver Tumor Program
Clinical Chief of Hepatology
University of Texas Southwestern 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Hepatocellular carcinoma, the most common form of primary liver cancer, often has a very poor prognosis because most cancers are found at a late stage when curative treatment is not available. However, if the cancer is found early, curative therapies are possible and patients can typically live longer than 5 years.

There is currently debate how at-risk patients with chronic liver disease should be screened – with an abdominal ultrasound alone or using a combination of abdominal ultrasound and a blood test called alpha fetoprotein. Many professional societies have traditionally recommended the former, i.e. ultrasound alone, given few data showing a benefit of adding alpha fetoprotein.

Our study examines all available literature examining this question and found using the two tests in combination significantly increases the likelihood of finding the cancer at an early stage. Whereas abdominal ultrasound misses over half of all cancers, using it in combination with alpha fetoprotein can detect two-thirds of cancers at an early stage. Continue reading