Clinical trial NCT01280825: The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
Official title: The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients Undergoing Routine Health Care
Heart Diseases
Inflammatory Bowel Diseases
Autoimmune Disease
Inflammatory Disease
Blood Coagulation Disorders
Hepatitis C
Non-Metastatic Neoplasm
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Feasibility of incorporating pharmacogenomic testing into routine medical care
timeFrame: 5 years
Secondary outcomes:
measure: Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting
timeFrame: 5 years
Other outcomes:
measure: To determine whether access to pharmacogenomic information improves satisfaction with care.
timeFrame: 5 years
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Peter H O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: