Author Interviews, Biomarkers, Gender Differences, Kidney Disease, NEJM, Race/Ethnic Diversity / 26.01.2023

MedicalResearch.com Interview with: Prof. dr. Hans Pottel KU Leuven Kulak Department of Public Health and Primary Care Belgium MedicalResearch.com: What is the background for this study? Response:  The glomerular filtration rate (GFR) is used to diagnose patients with chronic kidney disease and is also used to adjust the dose of drugs that are eliminated by the kidneys. An accurate estimation of GFR is considered of importance in the management of kidney health in patients. In 2021 we published a new serum creatinine based equation, called the European Kidney Function Consortium (EKFC) equation (Pottel H. et al, Development and Validation of a Modified Full Age Spectrum Creatinine-Based Equation to Estimate Glomerular Filtration Rate : A Cross-sectional Analysis of Pooled Data. Ann Intern Med (2021) 174: 183-191): EKFC-eGFR = 107.3 / [Biomarker/Q]a x [0.990(Age – 40) if age > 40 years] With a = 0.322 if Biomarker/Q is less than 1, and a = 1.132 if Biomarker/Q is 1 or more. The equation can easily be interpreted: the leading coefficient equals the glomerular filtration rate (GFR) of 107.3 mL/min/1.73m², which is the average GFR in healthy children (aged > 2 years), adolescents and young adults. The average healthy GFR remains constant until the age of 40 years, and starts decreasing beyond that age. The GFR is inversely related to the ‘rescaled’ biomarker. The rescaling factor (Q) is the average biomarker value for healthy people of a specific population (e.g. children, adult men, adult women, white people, black people, …). Biomarker/Q equals ‘1’ for the average healthy person, corresponding with eGFR = 107.3 mL/min/1.73m² (up to 40 years of age). It should be noted that for serum creatinine, the Q-value depends on sex and race. Our hypothesis was that the above equation is valid for any renal biomarker, on the condition that the biomarker is appropriately scaled. We showed that the same equation was able to estimate GFR from 2 years to oldest ages. In the current study we tested and validated our hypothesis by applying the above formula for appropriately ‘rescaled’ cystatin C. (more…)
Author Interviews, Biomarkers, Heart Disease, JACC, University of Michigan / 21.12.2022

MedicalResearch.com Interview with: Salim S. Hayek MD Assistant Professor Medical Director of the Frankel Cardiovascular Center Clinics University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Essentially, immune checkpoint myocarditis is a rare but deadly complication of immune checkpoint inhibitors – amazing drugs that are increasingly used for the treatment of various cancers. Most patients present late, and when they do, they’re very ill and have a 50% chance of death. Diagnosing ICI myocarditis is challenging, given there is no one test that can differentiate it from other causes of cardiac injury. It is important to diagnose it fast, early and accurately in order to start immunosuppressive therapy as soon as possible. What we did in this study was look at commonly measured biomarkers in all patients receiving ICI at the University of Michigan. What we found was that patients who developed ICI myocarditis had early signs of muscle destruction (rise in CPK) levels and hepatitis (rise in AST, ALT), and that all patients who had myocarditis with bad outcomes had rises in all of the aforementioned biomarkers. Creatinine phosphokinase was the most sensitive. (more…)
Author Interviews, Biomarkers, JAMA, Tobacco Research / 09.11.2022

MedicalResearch.com Interview with: Dr. Hongying Daisy Dai, PhD Professor and Associate Dean of Research The College of Public Health University of Nebraska Medical Center. MedicalResearch.com: What is the background for this study? Response: Tobacco use landscape has been changing in the United States with fewer combustible cigarette smokers and more e-cigarette and other emerging tobacco users. Nicotine concentration level is a key product characteristic of modern e-cigarette products and high-nicotine vaping devices have recently become available. This study seeks to examine whether biomarkers of exposure to tobacco-related toxicants have changed since 2013 among adult nicotine e-cigarette users, non-nicotine e-cigarette users, and cigarette smokers. (more…)
Author Interviews, Biomarkers, Cancer Research, Hepatitis - Liver Disease / 18.05.2022

MedicalResearch.com Interview with: Yujin Hoshida, MD, PhD Director, Liver Tumor Translational Research Program CPRIT Scholar in Cancer Research Harold C. Simmons Comprehensive Cancer Center Professor of Internal Medicine Division of Digestive and Liver Diseases, Department of Internal Medicine University of Texas Southwestern Medical Center MedicalResearch.com:  What is the background for this study?  Response: Liver cancer is the fastest rising cause of cancer-related death in the U.S. with the sharply growing epidemic of obesity and non-alcoholic fatty liver disease. Late diagnosis at advanced stage is the main reason for the poor survival of liver cancer patients. Therefore, professional societies recommend semi-annual liver cancer screening for early diagnosis. However, it's practically infeasible due to the vast size of patient population (estimated to affect one-fourth of population). Thus, we urgently need tools to identify a small subset of patients with elevated liver cancer risk, on which we can concentrate our effort of screening. (more…)
Author Interviews, Biomarkers, Cancer Research, Colon Cancer / 18.05.2022

MedicalResearch.com Interview with: AmirAli Talasaz Ph.D. co-CEO, Guardant Health MedicalResearch.com:  What is the background for this announcement? Response: On May 2, Guardant Health announced the availability of Shield™, our first blood-based test for the detection of early-stage colorectal cancer (CRC). Colorectal cancer is the second-leading cause of cancer deaths in the U.S., so this announcement represents a tremendous public health opportunity. Here’s why: This new test will help people identify more CRC at its earliest stages, when it is most treatable. It offers an accurate, easy-to-complete, blood-based approach to CRC screening. It can be completed with a convenient blood draw during any healthcare provider visit.  (more…)
Author Interviews, Biomarkers, BMJ, Gastrointestinal Disease, Pancreatic / 09.03.2022

MedicalResearch.com Interview with: Ece Kartal, PhD Postdoctoral Fellow Saez-Rodriguez Group Universitätsklinikum Heidelberg Institute for Computational Biomedicine Heidelberg MedicalResearch.com:  What is the background for this study?    Response: Pancreatic cancer is one of the deadliest types of cancer: although incidence rates are relatively low (only few people develop pancreatic cancer in their lifetimes), it has a high lethality, with a five year survival rate of less than ~5%. Pancreatic cancer symptoms are generally unspecific so that the disease is usually detected very late which further  limits therapeutic options. In light of this, earlier detection of pancreatic cancer could dramatically improve prognosis, but there are currently no affordable and non-invasive tests available in the clinic. For pancreatic ductal adenocarcinoma (PDAC),the most common form of pancreatic cancer, it was previously found that the oral, gut and pancreatic microbiome are risk factors and may affect prognosis . (more…)
Author Interviews, Biomarkers, Heart Disease, NEJM / 03.03.2022

MedicalResearch.com Interview with: PJ Devereaux MD PhD Professor of Medicine, and of Health Research Methods, Evidence and Impact McMaster University President of the Society of Perioperative Research and Care  MedicalResearch.com:  What is the background for this study?  Response: More than 1 million patients undergo cardiac surgery in the United States and Europe annually. Although cardiac surgery has the potential to improve and prolong a patient’s quality and duration of life, it is associated with complications. Prognostically important heart injury – detected by an elevated blood concentration of either cardiac troponin or creatine kinase myocardial MB isoform (CK-MB) – is one of the most common complications after cardiac surgery and is associated with increased mortality. Although elevated CK-MB was historically used to define heart injury after cardiac surgery, this assay is no longer available in many hospitals worldwide, and consensus statements have recommended high-sensitivity cardiac troponin assays as the preferred biomarker. Based on expert opinion, the Fourth Universal Definition of Myocardial Infarction suggested that a cardiac troponin concentration >10 times the upper reference limit, in patients with a normal baseline measurement, should be the threshold used in the diagnosis of heart attack along with evidence of ischemia (e.g., ischemic ST changes on an ECG) in the first 48 hours after coronary artery bypass grafting (CABG). Although the Academic Research Consortium-2 Consensus stated there was no evidence-based threshold for cardiac troponin after CABG, they endorsed a threshold for the diagnosis of heart attack of ≥35 times the upper reference limit together with new evidence of ischemia, based on expert opinion. They also defined a threshold of ≥70 times the upper reference limit as a stand-alone criterion for clinically important periprocedural myocardial injury. Globally, many hospitals now use high-sensitivity cardiac troponin assays; however, limited data are available to define a prognostically important degree of myocardial injury after cardiac surgery based on these assays. We undertook the Vascular Events in Surgery Patients Cohort Evaluation (VISION) Cardiac Surgery Study to examine clinical outcomes after cardiac surgery. A primary objective was to determine the relationship between postoperative levels of high-sensitivity cardiac troponin I and the risk of death 30 days after cardiac surgery.  (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers / 11.11.2021

MedicalResearch.com Interview with: Joshua D. Grill, PhD Professor, Psychiatry & Human Behavior School of Medicine Professor, Neurobiology and Behavior School of Biological Sciences University of California, Irvine MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease is a major public health challenge. More than 6 million Americans have the disease, which causes cognitive problems and eventual dependence on others for daily function. Scientists understand that the disease begins in the brain years before memory and other thinking problems begin and the AHEAD Study aims to intervene in this window of time, to see if a drug that targets these brain changes can delay or prevent symptoms of the disease.   (more…)
Author Interviews, Biomarkers, Heart Disease, JAMA, Technology / 05.10.2021

MedicalResearch.com Interview with: Pinar Zorlutuna, PhD Sheehan Family Collegiate Professor of Engineering Aerospace and Mechanical Engineering Chemical and Biomolecular Engineering (Concurrent) Bioengineering Graduate Program University of Notre Dame  MedicalResearch.com: What is the background for this study? Response: Acute myocardial infarction (AMI) is the primary cause of death among cardiovascular diseases. The current clinical standard of diagnosis combines echocardiogram (ECG) and several circulating protein biomarkers from plasma. In their current state, both are incapable of distinguishing between patients with and without complete coronary occlusion, unless additional invasive testing is implemented, and both have significant false positive rates. MicroRNAs (miRNAs) have shown great potential as rapid and discriminating biomarkers for acute myocardial infarction (AMI) diagnosis. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus, JAMA / 28.08.2021

MedicalResearch.com Interview with: Laura Holberger, PhD Vice President, Strategic Partnerships Biolabs MedicalResearch.com: What is the background for this study? Response: Dr. Laura Holberger is the lead author of a JNO article published today describing the results of a research study done on behalf of BioLabs, a global network of coworking laboratory spaces, and the Cambridge Consortium for Rapid COVID Tests (CCRCT). BioLabs co-sponsored the study which helped validate a high-frequency testing protocol using an antigen test for COVID-19 under development by E25Bio Inc., a biotechnology company that develops rapid tests for infectious diseases.  The study involved twice-weekly testing of members and affiliates working in person at coworking laboratories in Cambridge and Boston, Massachusetts from September 2020 through March 2021. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer / 18.06.2021

MedicalResearch.com Interview with: Dr. Frank Vicini, MD, FACR, FASTRO Principal Investigator Radiation Oncologist at GenesisCare Member of NRG Oncology MedicalResearch.com: Would you briefly explain what is meant by DCIS? Response: DCIS stands for ductal carcinoma in situ and indicates the presence of abnormal cells inside a milk duct in one or both breasts. Sometimes referred to as Stage 0 (zero), it is considered the earliest form of breast cancer and is noninvasive. The tumor has not yet left the duct-- a passageway that transports milk from the breast lobules to the nipple-- and begun to invade the healthy tissue surrounding it. Standard treatment options for DCIS include surgery, radiation therapy and hormonal therapy. (more…)
Author Interviews, Biomarkers, Cancer Research, Science / 18.02.2021

MedicalResearch.com Interview with: Muhammed Murtaza M.B.B.S. (M.D.), Ph.D. Translational Genomics Research Institute Phoenix, AZ MedicalResearch.com: What is the background for this study? Response: Liquid biopsies and cell-free DNA analysis using blood samples have transformed cancer diagnostics in recent years. We started this project wondering whether cell-free DNA in urine is a viable alternative to blood, since urine could be collected completed non-invasively. Our very first experiment showed the lengths of DNA fragments in urine very similar across healthy individuals, leading us to wonder whether urine was actually as randomly degraded as we had previously thought. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus / 25.01.2021

MedicalResearch.com Interview with: Marlene Cano MD. PhD. Post-Doctoral Research Fellow in Pulmonary Transplant Immunology Division of Pulmonary and Critical Care Department of Medicine Washington University/Barnes-Jewish Hospital Saint Louis, MO MedicalResearch.com: What is the background for this study? How does this test differ from other tests for COVID-19?   Response: We know COVID-19 causes a wide spectrum of disease, and that while many develop only mild uncomplicated illness, others develop severe respiratory failure, multi-organ failure and death. These patients often require prolonged hospitalization, ICU level care and even mechanical intubation for respiratory support. However, we still do not have a great way to identify which patients are likely to develop severe disease. We felt it was important to have a test that could act as sort of a ‘biomarker’ that we could measure early in COVID-19 patients and would help predict which patients would develop severe disease. From prior work, we knew that mitochondrial DNA, which are proinflammatory molecules that are released into the circulation from damaged organs could be this such ‘biomarker’. So, we measured the levels of mitochondrial DNA circulating in the plasma of patients with COVID-19 at the time they first presented to the hospital. Then we investigated if higher levels of mitochondrial DNA indeed predict the development of more severe disease. Currently there are no ‘biomarker’ tests specific for COVID-19. We do currently measure levels of other markers in the hospital that we feel might help us assess overall how sick patients may be, but these are very non-specific and assess only level of inflammation. This test instead can measure level of tissue injury. (more…)
Author Interviews, Biomarkers, Cancer Research / 07.10.2020

MedicalResearch.com Interview with: Padma Sundar, Senior Vice President of Commercial , OncocyteTM oncocyte.com MedicalResearch.com:  What is the background for this announcement? How common is Stage I-IIA non-squamous NSCLC?  DetermaRxTM is a treatment stratification test to identify patients with Stage I-IIA non-squamous NSCLC who may benefit from adjuvant chemotherapy.
  • Stage I-IIA non-squamous NSCLC represents ~20% of the lung cancer population and 40,000 patients annually in the U.S.1
  • Patients with this diagnosis usually undergo surgical resection and are presumed “cured”. While these patients are presumed “cured”, the recurrence rate in early-stage NSCLC of 30-50%. Usually, these recurrences happen within the first two years after surgery and are likely due to the presence of occult distant metastasis at the time of surgery.2
  • Until now, there has not been a validated means of identifying which early-stage patients are at a higher risk of disease recurrence and require adjuvant chemotherapy, versus those patients that are likely cured by surgery alone.
(more…)
Author Interviews, Biomarkers, Cancer Research / 20.08.2020

MedicalResearch.com Interview with: Dr. Alexey Aleshin, M.D., MBA Senior Medical Director Natera MedicalResearch.com: What is the background for this study? Response: Checkpoint inhibitor-based immunotherapies (ICI)  have changed the management of a range of cancers of diverse histologies. While these therapies are well tolerated and efficacious, only a minority (<20%) of patients respond to treatment or derive durable clinical benefit from them, highlighting the need for a pan-cancer biomarker that can predict response prior to, or shortly after, treatment initiation. With immune checkpoint inhibitors (ICIs) rapidly becoming a cornerstone of cancer therapy, early determination of response to ICI treatment can optimize patient benefit and minimize the risk of toxicities, while potentially reducing unnecessary treatment and costs to patients and payers. Additionally, due to the nature of immune checkpoint inhibition, atypical patterns of response have emerged. For instance, tumor pseudoprogression — a transient increase in tumor size due to the infiltration of immune cells, followed by delayed shrinkage — has been reported in as much as 10% of patients receiving ICI therapy. Distinguishing pseudoprogression from true progression is clinically important to avoid premature discontinuation of a treatment that may have future benefit, or delay the initiation of an alternative line of therapy. However, they are hard to differentiate using current imaging techniques. Our study published in Nature Cancer earlier this month, demonstrates that bespoke circulating tumor DNA (ctDNA) testing may be a valuable tool that sheds light on both of these issues. (more…)
Author Interviews, Biomarkers, Lymphoma / 14.08.2020

MedicalResearch.com Interview with: Dr. Ivana Špaková Pavol Jozef Šafárik University Košice, Slovakia MedicalResearch.com: What is the background for this study? Response:  The background is the plenty of space for studying "waste metabolites" which tell us more about the metabolism of the whole body as well as about the metabolism of the smallest compartment - cell. So we decided to study what is the difference in urine spectra (absorbance, excitation, and emission spectra) in patients with malignant melanoma and healthy subjects without positive cancer history. MedicalResearch.com: What are the main findings? Response: The main findings are "discovery" (it is not true discovery because the target molecules or metabolites are known for decades) of molecules{metabolites which together describe the stage of malignant melanoma. These findings could be used for future tracking the patient's response for treatment or for tracking the previously treated patients for malignant melanoma and are healthy at the moment of sampling. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus / 21.07.2020

MedicalResearch.com Interview with: Gil Garnier PhD Director and Professor Bioresource Processing Research Institute of Australia (BioPRIA) PALS ARC Industry Transformation Research Hub Department of Chemical Engineering Monash University MedicalResearch.com: What is the background for this study? Response: We wanted to develop a test that would be: 1) Reliable and fast to perform, 2) Easy and fast to manufacture, 3) Easy and fast to distribute and be adopted by the Health care community. We also wanted to capitalize on our vast expertise and experience from developing novel blood typing tests. Our strategy was to develop a serology COVID test using the current Gel card technology available in most hospital and blood laboratories throughout the world. Equipment and expertise are already available from point of care setting to high throughput/automated systems measuring 100-200 test/ h. Also, these cards are currently produced by many companies all over and these can be shipped all international. (more…)
Author Interviews, Biomarkers, COVID -19 Coronavirus / 17.07.2020

MedicalResearch.com Interview with: Abdi Ghaffari, Ph.D. Associate Professor (adjunct) Dept. of Pathology and Molecular Medicine Queen’s University MedicalResearch.com: What is the background for this study? Response: SARS-CoV-2 virus has infected millions and changed our way of life by placing nearly 3 billion people under lockdown or some form of physical isolation. In the absence of a vaccine or reliable treatment, diagnostic testing must be a pillar of public health policy to control further spread of the virus and to guide gradual removal of lockdown measures. COVID-19 antibody diagnostic tests are being increasingly used to assess the protective immunity status in the population. There are over 100 different COVID-19 antibody tests developed by companies worldwide in an effort to address this need. However, companies’ reported performance data are not always in line with the actual performance of these diagnostic tests in the real-world. In this work, we conducted a systemic review of independent studies (sponsored by academic or government institutions) that aimed to validate the performance of currently available COVID-19 antibody tests on the market.  (more…)
Author Interviews, Biomarkers, Cancer Research / 28.06.2020

MedicalResearch.com Interview with: Dr. Kathryn Lang VP, Outcomes and Evidence Guardant Health  MedicalResearch.com: What is the background for this study? Response: Despite a wide variety of screening methods available and increasing public awareness of the value of early detection, colorectal cancer (CRC) remains a leading cause of cancer-related deaths.  However nearly 1 in 3 adults in the United States  is not compliant with screening recommendations, with most citing that current screening methods are time consuming, unpleasant (stool-based testing), and in the case of colonoscopy, invasive. A blood-based CRC screening test could improve compliance rates by providing physicians with an opportunistic, in-office screening modality. However, demonstrating the clinical utility of blood-based cell-free circulating tumor DNA (ctDNA) fractions  for the detection of cancer in asymptomatic individuals has thus far been challenged by the failure to achieve clinically meaningful sensitivity and specificity thresholds due to significantly lower tumor cell-free free DNA  fractions and the increasing relevance of biological confounders. The multi-modal approach of Guardant Health’s LUNAR-2 assay (genomics, methylation and fragmentomics) coupled with advanced bioinformatic analysis and a focused approach of honing in on the unique signals of CRC  has been shown in previously reported cohorts to perform with sensitivity and specificity which satisfies the needs of clinicians in screening for CRC. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, Colon Cancer / 26.06.2020

MedicalResearch.com Interview with: Guardant HealthVan Morris, M.D. Department of Gastrointestinal Medical Oncology Division of Cancer Medicine MD Anderson Center MedicalResearch.com: What is the background for this study? Response: Stage II colon cancer is diagnosed in approximately 25% of all colon cancer cases.  Oncologists do not have a reliable biomarker to identify patients who do or do benefit from adjuvant chemotherapy for this population of patients.  Circulating tumor DNA is shed by tumor cells as they die and harbors somatic mutations which distinguish its DNA from that of normal cells. Recently, circulating tumor DNA has shown great promise in distinguishing patients with colon cancer (as well as other solid tumors) that do or do not recur after surgery.  Here, patients who have detectable circulating tumor DNA - a surrogate for the presence of microscopic, minimal residual disease – inevitably recur, whereas the likelihood of recurrence is much lower for patients who do not have detectable ctDNA. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer / 30.05.2020

MedicalResearch.com Interview with: Francois-Clement Bidard, MD PhD Head of Breast Cancer Group, Institut Curie Professor of Med. Oncology, UVSQ/Paris MedicalResearch.com: What is the background for this study? Response: A timely question is how to optimize the endocrine therapy of ER+ HER2- metastatic breast cancers? Aromatase inhibitors (AI) are currently the standard of care in first line, in combination with CDK4/6 inhibitors. Mutations in the estrogen receptor gene (ESR1) can be detected in up to 40% of AI-resistant metastatic breast cancers, but no data was available in the current first line setting (AI combined to CDK4/6 inhibitor). This exploratory study of the first line PADA-1 study reports on the detection rate of ESR1 mutations in cell-free DNA from an “AI-sensitive” population (with no metastatic relapse during adjuvant AI therapy), before the start of therapy (at inclusion). As expected, we found a low prevalence of 3.2% in the general population (N=1,017 patients included). The prevalence of ESR1 mutations among subgroups appeared primarily driven by the type of adjuvant endocrine therapy: patients with prior exposure to adjuvant therapy with AI displayed the highest prevalence of ESR1 mutations (7.1%), followed by patients with no prior adjuvant endocrine therapy (mostly de novo stage IV; ESR1 mutation prevalence: 2.4%). Patients who received adjuvant endocrine therapy with no AI (e.g. tamoxifen only) had the lowest ESR1 mutation prevalence (1.2%). (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc). (more…)
Author Interviews, Biomarkers, Gastrointestinal Disease / 28.03.2020

MedicalResearch.com Interview with: Jean-Frederic Colombel MD The Henry D Janowitz Division of Gastroenterology Icahn School of Medicine at Mount Sina New York, NY 10029, USA MedicalResearch.com: What is the background for this study? Response: The goals of therapy in Crohn’s disease have shifted from mere control of symptoms also called clinical remission towards combination of clinical and endoscopic remission also called deep remission which is now considered as the new therapeutic “target”. However it has yet to be proven that targeting deep remission instead of clinical remission is able to stop the progression of Crohn’s disease towards bowel damage, complications and hospitalizations. This study is a post-hoc analysis of the CALM trial that was published in The Lancet in 2018 where newly diagnosed patients were randomized to escalate therapy based on symptoms only (control arm) or based on a combination of symptoms and two biomarkers namely C-reactive protein in blood and calprotectin in stools (tight control arm). (more…)
Author Interviews, Biomarkers, Diabetes, Diabetes Care, Johns Hopkins / 26.03.2020

MedicalResearch.com Interview with: Olive Tang, MD/PhD Student Johns Hopkins School of Medicine   Elizabeth Selvin, PhD, MPH Professor of Epidemiology & Medicine Director, Cardiovascular and Clinical Epidemiology Department of Epidemiology Welch Center for Prevention, Epidemiology and Clinical Research and the Johns Hopkins Bloomberg School of Public Health MedicalResearch.com: What is the background for this study? Response: The best approach to diabetes management in older adults is unclear. A new blood test called high-sensitivity troponin can detect damage to the heart, even in people without any signs or symptoms of heart disease. (more…)
Author Interviews, Biomarkers, Lung Cancer, Stanford / 09.03.2020

MedicalResearch.com Interview with: Professor Dr. Andreas Keller Stanford University School of Medicine Office Department of Neurology and Neurological Sciences Chair for Clinical Bioinformatics Saarbrücken, Germany MedicalResearch.com: What is the background for this study? Response: Lung cancer is among the three most common cancers and the leading cause of cancer-related deaths worldwide. The overall low survival rate of patients with lung cancer calls for improved detection tools to enable better treatment options and improved patients’ outcomes. To detect lung tumors, liquid biopsy-based strategies are increasingly explored, that are biomarkers, which are identifiable in body fluids such as human blood. The clinical application of biomarkers is, however, largely hampered by the relatively small numbers of cases that have been analyzed in the majority of the preclinical studies including the studies on lung cancer.  (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers, Heart Disease / 25.02.2020

MedicalResearch.com Interview with: Prof. Konstantinos Stellos, MD, DM, MRCP, DSc, FAHA, FESC Professor of Medicine, Chair of Cardiovascular Medicine, Chair of Epitranscriptomics Lead, Vascular Biology & Medicine Theme Hon. Consultant Cardiologist, Newcastle Hospitals NHS Foundation Trust Biosciences Institute Faculty of Medical Sciences Newcastle University MedicalResearch.com: What is the background for this seminar? Can you tell us a little about how amyloid is made and stored? Response: Patients are afraid that they may die due to a heart attack - a major cause of death worldwide- or if they live long they may get dementia compromising severely their quality of life in their last years of life. Many years ago we asked the question whether there is a link between these two ageing-associated diseases. For this reason we studied the clinical value of amyloid-beta peptides in patients with coronary heart disease. We chose to study the amyloid-beta peptides, which are the cleavage product of the beta- and gamma-secretases of the mother protein amyloid precursor protein, because amyloid-beta plaques in brain is the hallmark of Alzheimer's disease. Following amyloid precursor protein (APP) gene transcription, APP is cleaved in the nonamyloidogenic pathway (plasma membrane) by α- and γ- secretases or in the amyloidogenic pathway (endosomes) by β- and γ- secretases. The later pathway generates amyloid beta (Αβ) peptides that are released extracellularly. Αβ accumulation in blood or tissues may result from enhanced production/cleavage or by impaired degradation and/or clearance. The related mechanisms are depicted in Figure 2 of our publication in JACC: http://www.onlinejacc.org/content/75/8/952  (more…)
Author Interviews, Biomarkers, Heart Disease, JAMA, UCLA / 09.01.2020

MedicalResearch.com Interview with: Olujimi A. Ajijola, MD, PhD Neurocardiology Research Center of Excellence Cardiac Arrhythmia Center University of California, Los Angeles MedicalResearch.com: What is the background for this study? Response: It hadn’t been understood why some people with basic heart failure might live longer than others despite receiving the same medications and medical device therapy. Through this research we set out to determine whether a biomarker of the nervous system could help explain the difference. This study revealed a biomarker that can specifically predict which patients with “stable” heart failure have a higher risk of dying within one to three years. (more…)
Annals Internal Medicine, Author Interviews, Biomarkers, Heart Disease / 23.12.2019

MedicalResearch.com Interview with: Dr. PJ Devereaux MD, PhD, FRCP(C) Director of the Division of Cardiology Scientific Leader Anesthesiology, Perioperative Medicine, and Surgical Research Group Population Health Research Institute McMaster University  MedicalResearch.com: What is the background for this study? Response: There is an ethical obligation to provide patients with an accurate estimation of the potential benefits of surgery and the potential risks, to facilitate informed decision making about the appropriateness of surgery.  There are two common approaches to risk estimation. First, physicians commonly use clinical risk indices.  Based upon a patient’s clinical history (e.g., history of prior heart attack or stroke) an estimate of perioperative risk is determined.  Research demonstrates that these clinical risk indices have suboptimal risk discrimination capabilities, and they will underestimate risk in many patients. The second approach that has commonly been used is to have patients undergo an expensive and time consuming non-invasive cardiac test (e.g., stress nuclear cardiac study).  Although these non-invasive cardiac tests can enhance risk estimation in some patients who will have a perioperative cardiac event, these tests more commonly exaggerate risk in patients who will not have a complication. (more…)
Author Interviews, Biomarkers, Cancer Research / 21.12.2019

MedicalResearch.com Interview with: https://www.kariusdx.com/ Dr. Asim Ahmed MD co-author of the study Senior medical director at Karius  MedicalResearch.com: What is the background for this study? Would you briefly explain the basis of the Karius Test? Response: The Karius Test is a non-invasive blood test that uses next-generation sequencing of microbial cell-free DNA to rapidly detect over 1,400 bacteria, DNA viruses, fungi, and other pathogens. Doctors primarily use the test to detect specific causative pathogens, complicated pneumonia, cardiovascular infections, and infections in immunocompromised hosts. The Karius Test is transforming how doctors diagnose infectious diseases by helping doctors identify the precise pathogens infecting patients. The Karius Test offers a higher diagnostic yield and faster time-to-diagnosis than conventional tests - with the potential to eliminate invasive diagnostic procedures like biopsies. (more…)
Author Interviews, Biomarkers, Hematology, Transplantation / 09.12.2019

MedicalResearch.com Interview with: Hrishikesh Srinagesh MD The Tisch Cancer Institute at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Graft-versus-host disease (GVHD) is the leading cause of non-relapse mortality (NRM) after allogeneic hematopoietic cell transplantation (HCT). Acute GVHD occurs in approximately 50% of HCT patients and targets the skin, liver, and gastrointestinal tract primarily. The change in clinical symptoms (e.g. reduction in volume of diarrhea) is used as the primary endpoint in most trials of acute GVHD treatment, but more accurate metrics are needed to predict long-term survival. Over the past decade, the Mount Sinai Acute GVHD International Consortium (MAGIC) has studied two biomarkers important in GVHD pathogenesis: suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3 alpha (REG3). These proteins are shed into the bloodstream when the gastrointestinal tract is damaged during GVHD, the most lethal form of acute GVHD. The concentrations of ST2 and REG3 can be used generate an individual’s estimated probability of 6 month NRM known as the MAGIC Algorithm Probability (MAP). Our study evaluated whether the MAP measured at the start of GVHD treatment and four weeks later could predict long-term survival and we compared the MAP to clinical response after four weeks, the gold standard of response.  (more…)