The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01280825

Enrollment

1200

Registered

2011-01-21

Start date

2011-01-14

Completion date

2027-12-14

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Disease, Blood Coagulation Disorders, Heart Diseases, Hepatitis C, Inflammatory Bowel Diseases, Inflammatory Disease, Non-Metastatic Neoplasm, Patients Undergoing Routine Health Care

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Feasibility of incorporating pharmacogenomic testing into routine medical care	5 years

Secondary

Measure	Time frame
Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting	5 years

Countries

United States

Contacts

CONTACT1200 Patients Project Study Team

cpt1200@uchicago.edu(773) 834-1759

CONTACTCancer Clinical Trials Office

cancerclinicaltrials@bsd.uchicago.edu1-855-702-8222

PRINCIPAL_INVESTIGATORPeter H O'Donnell, MD

University of Chicago

Outcome results