- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280825
The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
January 26, 2024 updated by: University of Chicago
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: 1200 Patients Project Study Team
- Phone Number: (773) 834-1759
- Email: cpt1200@uchicago.edu
Study Contact Backup
- Name: Cancer Clinical Trials Office
- Phone Number: 1-855-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Adult Patients
Adults receiving health care at the University of Chicago Medical Center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility of incorporating pharmacogenomic testing into routine medical care
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Find out whether availability of pharmacogenomic information impacts drug decision making in the health care setting
Time Frame: 5 years
|
5 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether access to pharmacogenomic information improves satisfaction with care.
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter H O'Donnell, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 14, 2011
Primary Completion (Estimated)
November 14, 2027
Study Completion (Estimated)
December 14, 2027
Study Registration Dates
First Submitted
January 19, 2011
First Submitted That Met QC Criteria
January 19, 2011
First Posted (Estimated)
January 21, 2011
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Immune System Diseases
- Hematologic Diseases
- Gastrointestinal Diseases
- Liver Diseases
- Hemorrhagic Disorders
- Gastroenteritis
- Flaviviridae Infections
- Intestinal Diseases
- Hepatitis, Viral, Human
- Hepatitis
- Heart Diseases
- Hemostatic Disorders
- Blood Coagulation Disorders
- Inflammatory Bowel Diseases
- Hepatitis C
- Autoimmune Diseases
Other Study ID Numbers
- 10-487-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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