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

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.
 
ClinicalTrials.gov Identifier: NCT01280825
Recruitment Status : Recruiting
First Posted : January 21, 2011
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date January 19, 2011
First Posted Date January 21, 2011
Last Update Posted Date March 7, 2023
Actual Study Start Date January 14, 2011
Estimated Primary Completion Date November 14, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 19, 2011)		 Feasibility of incorporating pharmacogenomic testing into routine medical care [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 19, 2011)		 Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 13, 2012)		 To determine whether access to pharmacogenomic information improves satisfaction with care. [ Time Frame: 5 years ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
Official Title The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood and DNA
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.
Condition
  • Patients Undergoing Routine Health Care
  • Heart Diseases
  • Inflammatory Bowel Diseases
  • Autoimmune Disease
  • Inflammatory Disease
  • Blood Coagulation Disorders
  • Hepatitis C
  • Non-Metastatic Neoplasm
Intervention Not Provided
Study Groups/Cohorts Adult Patients
Adults receiving health care at the University of Chicago Medical Center.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 19, 2011)		 1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 14, 2023
Estimated Primary Completion Date November 14, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: 1200 Patients Project Study Team (773) 834-1759 cpt1200@uchicago.edu
Contact: Cancer Clinical Trials Office 1-855-702-8222 cancerclinicaltrials@bsd.uchicago.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01280825
Other Study ID Numbers 10-487-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University of Chicago
Original Responsible Party Peter O'Donnell, MD, University of Chicago Medical Center
Current Study Sponsor University of Chicago
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Peter H O'Donnell, MD University of Chicago
PRS Account University of Chicago
Verification Date March 2023