NCT05391126 GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
| NCT ID | NCT05391126 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Reema A. Patel |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2022-09-28 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 178 participants in total. It began in 2022-09-28 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment. * Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed. * Age ≥ 18 years. * ECOG performance status ≤ 1. * Patients must have adequate organ and marrow function as defined below: * Measurable or non-measurable disease. Exclusion Criteria: * Patients who received prior treatment with irinotecan are excluded. * 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. * Pregnant women are excluded from this study. * Patients who are not planned for treatment of their cancer.
Contact & Investigator
Reema A Patel, MD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT05391126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05391126 currently recruiting?
Yes, NCT05391126 is actively recruiting participants. Contact the research team at reema.patel@uky.edu for enrollment information.
Where is the NCT05391126 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT05391126 clinical trial?
NCT05391126 is sponsored by Reema A. Patel. The principal investigator is Reema A Patel, MD at University of Kentucky. The trial plans to enroll 178 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.