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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Reema A. Patel
Study ID
NCT05391126
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Usual dosing per package insert.

Study Details

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.

Key Dates

Start date
Sep 28, 2022
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Genocare Guided
  • No Intervention: Usual Care

Primary Outcome Measure

Adverse Events Frequency [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Yvonne Taul
[email protected]
859-323-2354

Find similar trials in Lexington, KY

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Kentucky· Lexington, KY

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