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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

Study Description
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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.

Condition or disease
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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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
Actual Study Start Date : January 14, 2011
Estimated Primary Completion Date : November 14, 2023
Estimated Study Completion Date : December 14, 2023
Groups and Cohorts
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Group/Cohort
Adult Patients
Adults receiving health care at the University of Chicago Medical Center.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of incorporating pharmacogenomic testing into routine medical care [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting [ Time Frame: 5 years ]

Other Outcome Measures:
  1. To determine whether access to pharmacogenomic information improves satisfaction with care. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Whole blood and DNA

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280825


Contacts
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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

Locations
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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Peter H O'Donnell, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01280825    
Other Study ID Numbers: 10-487-A
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
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Hepatitis C
Inflammatory Bowel Diseases
Heart Diseases
Hemostatic Disorders
Blood Coagulation Disorders
Autoimmune Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Cardiovascular Diseases
Intestinal Diseases
Gastrointestinal Diseases
Gastroenteritis
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders