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GENOCARE: Genotype-Guided Dosing for Colorectal and Pancreatic Cancer

This study, called GENOCARE, is looking at how different doses of a chemotherapy drug called Irinotecan affect people with colorectal or pancreatic cancer. Researchers want to see if adjusting the dose based on your UGT1A1 gene type (genotype-guided dosing) is better than standard dosing. You might be able to join if you have stage I-IV pancreatic cancer or stage III-IV colorectal cancer, are at least 18 years old, and have a good performance status. The study will check for side effects (adverse events) over 6 months to see if the genotype-guided approach is more successful. All participants will have their UGT1A1 gene type checked at the start.

Study design
This is a randomized study, meaning participants are assigned by chance to one of two groups: genotype-guided dosing or usual care. The study plans to enroll 178 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, adverse events, is measured at 6 months, suggesting follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05391126

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

Recruiting
NAAges 18+InterventionalTreatment
Reema A. Patel
~178 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Irinotecan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events Frequency
Measured over 6 months

Conditions

Colorectal Cancer
Pancreatic Cancer

Explore related trials

Colorectal CarcinomaPancreatic CarcinomaUGT1A1 Gene

NCT05391126

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Kentucky

    Lexington, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Reema A Patel, MD
[email protected]
8592186650
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Adverse Events Frequency6 months

    To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a \*1/\*28 or \*1/\*1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care.