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

This study is currently recruiting participants.
Verified October 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Peter O' Donnell, University of Chicago
ClinicalTrials.gov Identifier:
NCT01280825
First received: January 19, 2011
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult Patients
Adults receiving health care at the University of Chicago Medical Center.

  Eligibility

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.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280825

Contacts
Contact: 1200 Patients Project Study Team (773) 834-1759 cpt1200@uchicago.edu

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

No publications provided

Responsible Party: Peter O' Donnell, Assistant Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01280825     History of Changes
Other Study ID Numbers: 10-487-A
Study First Received: January 19, 2011
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autoimmune Diseases
Blood Coagulation Disorders
Hemostatic Disorders
Neoplasms
Heart Diseases
Hepatitis
Hepatitis A
Hepatitis C
Inflammatory Bowel Diseases
Intestinal Diseases
Immune System Diseases
Hematologic Diseases
Vascular Diseases
 Cardiovascular Diseases
Hemorrhagic Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013