Studying how genetic testing can improve medication use in patients
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
This study is trying to see if using genetic testing can help doctors choose the right medications for patients with heart diseases, inflammatory bowel diseases, and autoimmune diseases to improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT01280825 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect DNA samples from patients receiving routine care at the University of Chicago Medical Center. The samples will be analyzed for genetic variations that may indicate a higher risk of side effects or a greater likelihood of benefit from specific medications. The findings will be shared with the patients' treating physicians, and the study will track how this genetic information is utilized in clinical practice. The focus is on patients with conditions such as heart diseases, inflammatory bowel diseases, and autoimmune diseases.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older who are receiving ongoing outpatient care and are taking at least one prescription medication.
Not a fit: Patients who are not currently on any prescription medications or those with a life expectancy of less than three years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized medication management, reducing adverse drug reactions and improving treatment outcomes.
How similar studies have performed: Other studies have shown promise in using pharmacogenomic testing to tailor medication therapies, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Peter H O'Donnell, MD — University of Chicago
- Study coordinator: 1200 Patients Project Study Team
- Email: cpt1200@uchicago.edu
- Phone: (773) 834-1759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.