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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01280825
• Other study ID #: 10-487-A
• Status: Recruiting
• Start date: January 14, 2011
• Est. completion date: December 14, 2027

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: 1200 Patients Project Study Team
• Phone: (773) 834-1759
• Email: cpt1200[@]uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 14, 2027
• Est. primary completion date: November 14, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To determine whether access to pharmacogenomic information improves satisfaction with care.		5 years
Primary	Feasibility of incorporating pharmacogenomic testing into routine medical care		5 years
Secondary	Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting		5 years