NCT05391126Recruiting
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 20 May 2022
- Start date
- 28 Sept 2022
- Primary completion date
- May 2027
- Lead sponsor
- Reema A. Patel
- Diseases
- Pancreatic cancer, Colorectal cancer
- NCT number
- NCT05391126
What you commit to
- Study type: Interventional
- Planned participants: 178
- From 28 Sept 2022 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received prior treatment with irinotecan are excluded.
Other illness
- 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.
- Patients who are not planned for treatment of their cancer.
Other
- Pregnant women are excluded from this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.