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

NCT01280825 | Recruiting

• 1 other identifier: 10-487-A
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of incorporating pharmacogenomic testing into routine medical care

  5 years

Secondary Outcomes (1)

• Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting

  5 years

Other Outcomes (1)

• To determine whether access to pharmacogenomic information improves satisfaction with care.

  5 years

Study Arms (1)

Adult Patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults receiving ongoing routine medical care and regularly using at least 1 (but no more than 6) prescription medications at the time of enrollment.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and DNA

MeSH Terms

Conditions

Heart Diseases; Inflammatory Bowel Diseases; Autoimmune Diseases; Blood Coagulation Disorders; Hepatitis C

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases

Study Officials

• Peter H O'Donnell, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

1200 Patients Project Study Team

CONTACT

(773) 834-1759; cpt1200@uchicago.edu

Cancer Clinical Trials Office

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 21, 2011
• Study Start: January 14, 2011
• Primary Completion (Estimated): November 14, 2027
• Study Completion (Estimated): December 14, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)