RECRUITING

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

Conditions

Patients Undergoing Routine Health Care Heart Diseases Inflammatory Bowel Diseases Autoimmune Disease Inflammatory Disease Blood Coagulation Disorders Hepatitis C Non-Metastatic Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2011-01-14

Study Completion:2027-12-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01280825

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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

Study Contact

1200 Patients Project Study Team

CONTACT

(773) 834-1759

cpt1200@uchicago.edu

Cancer Clinical Trials Office

CONTACT

1-855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Peter H O'Donnell, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Peter H O'Donnell, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2011-01-14

Study Completion Date2027-12-14

Study Record Updates

Study Start Date2011-01-14

Study Completion Date2027-12-14

Terms related to this study

Additional Relevant MeSH Terms

Patients Undergoing Routine Health Care
Heart Diseases
Inflammatory Bowel Diseases
Autoimmune Disease
Inflammatory Disease
Blood Coagulation Disorders
Hepatitis C
Non-Metastatic Neoplasm