Alcoholic Hepatitis Network Observational Study

Status Recruiting

Clinical Trial Summary

The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, saliva, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcoholic hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcoholic hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A "biological sample" is usually blood, but can be any body fluid. "Personal Health Information" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits.

Clinical Trial Description

What should I know about this research? - Someone will explain this research to you. - Taking part in this research is voluntary. Whether you take part is up to you. - If you don't take part, it won't be held against you. - You can take part now and later drop out, and it won't be held against you - If you don't understand, ask questions. - Ask all the questions you want before you decide. How long will I be in this research? We expect that your taking part in this research will last up to 6 months, after the 6 months we will look in your medical records every 180 days for up to five years. Why is this research being done? The purpose of this research is to create a clinical database and bio-repository to study alcoholic hepatitis. What happens to me if I agree to take part in this research? If you decide to take part in this research study, the general procedures include: 1) allowing the investigators to review your medical records, 2) answering questions about you and your health, 3) completing questionnaires about alcohol use, 4) having a physical exam and blood drawn, and 5) providing urine and stool samples. Could being in this research hurt me? The most important risks or discomforts that you may expect from taking part in this research include mild pain from blood draws and a small chance for a loss of confidentiality (e.g., unauthorized users gain access to sensitive and protected data about you). Will being in this research benefit me? It is not expected that you will personally benefit from this research. Possible benefits to others may include understanding specific health conditions in patients with alcoholic hepatitis or other diseases. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03850899
Study type	Observational
Source	Indiana University
Contact	Savannah Yarnelle
Phone	317-278-6424
Email	samussel@iu.edu
Status	Recruiting
Phase
Start date	April 17, 2019
Completion date	August 2024

View Details

See also
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