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

This study is currently recruiting participants.
Verified July 2017 by University of Chicago
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280825
First Posted: January 21, 2011
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
January 19, 2011
January 21, 2011
July 26, 2017
January 14, 2011
December 2017   (Final data collection date for primary outcome measure)
Feasibility of incorporating pharmacogenomic testing into routine medical care [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT01280825 on ClinicalTrials.gov Archive Site
Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting [ Time Frame: 5 years ]
Same as current
To determine whether access to pharmacogenomic information improves satisfaction with care. [ Time Frame: 5 years ]
Not Provided
 
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood and DNA
Non-Probability Sample
Adults receiving ongoing routine medical care and regularly using at least 1 (but no more than 6) prescription medications at the time of enrollment.
  • Patients Undergoing Routine Health Care
  • Heart Diseases
  • Inflammatory Bowel Diseases
  • Autoimmune Disease
  • Inflammatory Disease
  • Blood Coagulation Disorders
  • Hepatitis C
  • Non-Metastatic Neoplasm
Not Provided
Adult Patients
Adults receiving health care at the University of Chicago Medical Center.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
December 2017
December 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: 1200 Patients Project Study Team (773) 834-1759 cpt1200@uchicago.edu
United States
 
 
NCT01280825
10-487-A
No
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Peter H O'Donnell, MD University of Chicago
University of Chicago
July 2017