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

Sponsor

University of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT01280825

Collaborator

(none)

1,200

Enrollment

Location

143

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Undergoing Routine Health Care Heart Diseases Inflammatory Bowel Diseases Autoimmune Disease Inflammatory Disease Blood Coagulation Disorders Hepatitis C Non-Metastatic Neoplasm

Study Design

Study Type:

Observational

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 14, 2011

Anticipated Primary Completion Date :

Nov 14, 2022

Anticipated Study Completion Date :

Dec 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Adult Patients Adults receiving health care at the University of Chicago Medical Center.

Outcome Measures

Primary Outcome Measures

Feasibility of incorporating pharmacogenomic testing into routine medical care [5 years]

Secondary Outcome Measures

Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting [5 years]

Other Outcome Measures

To determine whether access to pharmacogenomic information improves satisfaction with care. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.