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

Recruiting

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

• Registration Number: NCT01280825
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01-14
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29
• Primary Completion: 2027-11-14
• Study Completion: 2027-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of incorporating pharmacogenomic testing into routine medical care	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States