The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Patients Undergoing Routine Health Care, Heart Diseases, Inflammatory Bowel Diseases, Autoimmune Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Feasibility of incorporating pharmacogenomic testing into routine medical care [Time frame: 5 years]
Secondary outcome measures (1)
- Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting [Time frame: 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Chicago Medical Center — Chicago
Identifiers
NCT: NCT01280825 · 10-487-A