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

  • STATUS
    Recruiting
  • End date
    Dec 14, 2022
  • participants needed
    1200
  • sponsor
    University of Chicago
Updated on 26 January 2021
cancer
enteropathy

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.

Details
Condition Gastroenteritis, Intestinal Diseases, Coagulopathy, Blood disorder, Autoimmune disease, Heart disease, Hepatitis C, Hepatitis C virus, Autoimmunity, Cardiovascular Disease, Inflammatory bowel disease, Patients Undergoing Routine Health Care, Inflammatory Disease, Non-Metastatic Neoplasm, Inflammatory Disorder, Bowel Dysfunction, Hematological Disorders, Cardiac Disease, Non-Metastatic Neoplasm, Non-Metastatic Neoplasm, inflammatory bowel diseases, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder, autoimmune diseases, autoimmune disorder, autoimmune disorders, clotting, bleeding diathesis, bleeding tendency, blood coagulation disorders, coagulopathies, bleeding disorders, coagulation disorder, bleeding disorder, clotting disorders, blood clotting disorders, Non-Metastatic Neoplasm, Non-Metastatic Neoplasm, Non-Metastatic Neoplasm
Clinical Study IdentifierNCT01280825
SponsorUniversity of Chicago
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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