Alcoholic Hepatitis Network Observational Study
- Conditions
- Alcoholic Hepatitis
- Registration Number
- NCT03850899
- Lead Sponsor
- Indiana University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1260
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Subjects With Clinical Data Collected 5 years
- Secondary Outcome Measures
Name Time Method Number of Subjects With Bio-samples Collected 5 years
Trial Locations
- Locations (9)
IU School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University Of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical School
🇺🇸Dallas, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States