The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing (NCT01280825) | Clinical Trial Compass
RecruitingNot Applicable
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
United States1,200 participantsStarted 2011-01-14
Plain-language summary
The purpose of this study is to collect DNA samples from patients undergoing routine care at the University of Chicago. These samples will be tested for differences in genes that may suggest greater risk of side effects or chance of increased benefit from certain medications. The results will be made available to the patient's treating physician and the researchers will track whether or not this information is used in routine health care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Receiving ongoing, out-patient care at the University of Chicago Medical Center under the routine care of a physician participating in this trial
* Life expectancy of at least 3 years
* Must be 18 years or older
* Must be taking at least 1 (but not more than 6) prescription medications at the time of enrollment OR be 65 years or older OR be reasonably expected to require the use of a prescription medication within the next 5 years
* Patients with certain diseases, or likely to receive or be receiving certain drugs, will be targeted particularly for enrollment in order to enrich the study for patients likely to have pharmacogenetically relevant interactions, including, but not limited to:
* Patients requiring specialized cardiology care
* Patients with inflammatory bowel diseases
* Patients with systemic autoimmune or inflammatory diseases
* Patients requiring long-term oral anticoagulation
* Patients with hepatitis C
* Patients with non-metastatic cancer
Exclusion Criteria:
* Patients with acute or chronic disease which could be reasonably expected to result in the patient's death within the next 3 years.
* Patients who have undergone, or are being actively considered for, liver or kidney transplantation.
* Inability to understand and give informed consent to participate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of incorporating pharmacogenomic testing into routine medical care