RECRUITING

Informing Pain Treatment Using Pharmacogenomic Analysis

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Conditions

AnalgesiaCancerCYP2D6PharmacogenomicOpioids

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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

This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.

Official Title

C-PAIN: Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment

Quick Facts

Study Start:2024-07-10
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06511401

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Persons receiving ongoing oncology care at the University of Chicago Medical Center for whom near-future pain opioid pain medication therapy is anticipated
  2. * Subjects must be at least 18 years of age.
  1. * Subjects taking an opioid at the time of enrollment, or within the past 30 days
  2. * Subjects who are currently undergoing palliative radiation
  3. * Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
  4. * Subjects with a history of or active blood cancer (e.g., leukemia).
  5. * Chronic kidney disease, as defined by Glomerular filtration rate (GFR) \< 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
  6. * Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin greater than or equal to1.5 mg/dL, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) greater than or equal to 2.5 X upper limit of normal\*. (\*Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\ greater than or equal to 5 X upper limit of normal if hepatic metastases are present).
  7. * Inability to understand and give informed consent to participate in the opinion of the investigator
  8. * Subjects who are known to be pregnant at the time of enrollment
  9. * Subjects who are enrolled in other Pharmacogenomic (PGx) studies

Contacts and Locations

Study Contact

Clinical Trials Intake
CONTACT
1-855-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Peter H O'Donnell
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Peter H O'Donnell, 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 Date2024-07-10
Study Completion Date2028-08

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Pharmacogenomic
  • Opioids

Additional Relevant MeSH Terms

  • Analgesia
  • Cancer
  • CYP2D6