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NCT05391126 · ClinicalTrials.gov registry record · NA

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

A NA study of Colorectal Cancer and Pancreatic Cancer, sponsored by Reema A. Patel.

Recruiting
Registry status
NA
Development phase
178
Enrollment target
1
Study location

NCT05391126: Recruiting NA study of Colorectal Cancer and Pancreatic Cancer, sponsored by Reema A. Patel.

NCT05391126 is a NA study of Colorectal Cancer and Pancreatic Cancer that is actively recruiting participants, run by Reema A. Patel. The registered enrollment target is 178 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05391126, a NA study of Colorectal Cancer and Pancreatic Cancer, is actively recruiting participants, sponsored by Reema A. Patel.

RECRUITING
Registry status
NA
Development phase
178 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Irinotecan

Study Locations (1)

Kentucky

  • University of Kentucky - Lexington

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2022-09-28
Est. Completion 2027-05
Phase NA
Reema A. Patel

2 total trials

What NCT05391126 shows while recruiting

NCT05391126 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (88% lower).

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Irinotecan is the first listed.

NCT05391126 reports a single indexed study location in Kentucky.

Frequently Asked Questions

What is clinical trial NCT05391126 about?

NCT05391126 is a clinical study titled "GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care". 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 g...

What is the current status of trial NCT05391126?

This trial is currently recruiting. It is a NA study. The enrollment target is 178 participants. The study started on 2022-09-28. Estimated completion is 2027-05.

What conditions does trial NCT05391126 study?

This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Cancer.

What interventions are being tested in trial NCT05391126?

The interventions under investigation include: Irinotecan (DRUG).

Who is sponsoring clinical trial NCT05391126?

This trial is sponsored by Reema A. Patel, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05391126 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05391126's enrollment target sits among peer trials

178 160th of 381 higher than 221 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05391126, the US trial registry maintained by the National Library of Medicine. NCT05391126 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.