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

NCT ID: NCT01280825

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-14

Study Completion Date

2027-12-14

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult Patients

Adults receiving health care at the University of Chicago Medical Center.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter H O'Donnell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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1200 Patients Project Study Team

Role: CONTACT

(773) 834-1759

Cancer Clinical Trials Office

Role: CONTACT

1-855-702-8222

Other Identifiers

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10-487-A

Identifier Type: -

Identifier Source: org_study_id

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