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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Chicago
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: January 19, 2011
Last updated: January 6, 2016
Last verified: January 2016
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Feasibility of incorporating pharmacogenomic testing into routine medical care [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To determine whether access to pharmacogenomic information improves satisfaction with care. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Whole blood and DNA

Estimated Enrollment: 1200
Study Start Date: January 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Adult Patients
Adults receiving health care at the University of Chicago Medical Center.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01280825

Contact: 1200 Patients Project Study Team (773) 834-1759

United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Peter H O'Donnell, MD University of Chicago
  More Information

Responsible Party: University of Chicago Identifier: NCT01280825     History of Changes
Other Study ID Numbers: 10-487-A 
Study First Received: January 19, 2011
Last Updated: January 6, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Autoimmune Diseases
Inflammatory Bowel Diseases
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Intestinal Diseases
Vascular Diseases processed this record on May 24, 2016