RECRUITING

GENOCARE: a Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

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Conditions

Colorectal CancerPancreatic Cancer

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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 prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (\*1/\*28) (heterozygotes) and usual UGT metabolizers (\*1/\*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (\*1/\*28, \*1/\*1) will be randomized to genotype-guided dosing versus usual care.

Official Title

GENOCARE: a Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

Quick Facts

Study Start:2022-09-28
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05391126

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. * Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
  2. * Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
  3. * Age ≥ 18 years.
  4. * ECOG performance status ≤ 1.
  5. * Patients must have adequate organ and marrow function as defined below:
  6. * Measurable or non-measurable disease.
  1. * Patients who received prior treatment with irinotecan are excluded.
  2. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
  3. * Pregnant women are excluded from this study.
  4. * Patients who are not planned for treatment of their cancer.

Contacts and Locations

Study Contact

Reema A Patel, MD
CONTACT
8592186650
reema.patel@uky.edu

Principal Investigator

Reema A Patel, MD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40506
United States

Collaborators and Investigators

Sponsor: Reema A. Patel

  • Reema A Patel, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

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 Date2022-09-28
Study Completion Date2027-05

Study Record Updates

Study Start Date2022-09-28
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Pancreatic Cancer