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UGT1A1 Genotyping in Taiwanese Cancer Patients

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05792943
Collaborator
(none)
100
Enrollment
19.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Irinotecan is commonly used to treat lung, colorectal, pancreatic, stomach, esophageal, and other types of cancer. The main metabolic pathway of SN-38, the active product of Irinotecan, is grape glycoalkaloid acidification by UDP - glucuronosyltransferase (UGT1A1) and then excreted through bile and urine. Clinically, Irinotecan treatment can cause many adverse reactions, and differences in UGT1A1 genotypes can lead to structural changes or functional defects in enzymes, causing reduced acidification of grape glycolaldehyde, and increasing Irinotecan side effects. Therefore, if the patient's ability to metabolize the drug can be assessed before taking the drug, it will be of great help in treatment.

Until 2021, cancer will remain the top ten causes of death in Taiwan, of which colorectal and pancreatic cancer rank third and seventh among the top ten cancers in Taiwan, respectively, and these two cancers often use complex chemotherapy including irinotecan. Routine detection of UGT1A1 genotype in patients with colorectal and pancreatic cancer before irinotecan treatment predicts the drug metabolism capacity of irinotecan and adjusts the dose, allowing patients receiving irinotecan to reduce the harm of side effects. At present, the UGT1A1 genotype evaluated is usually only UGT1A128, but the common UGT1A1 genotype in Taiwan also has UGT1A16 and UG1A1*63, etc. There is no literature on Taiwanese cancer patients with actual irinotecan chemotherapy, so this study aims to explore the influence of the UGT1A1 genotype and develop other UGT1A1 genotype test methods. It is expected that molecular testing tools can improve cancer precision medicine and provide personalized medicine.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Impact of Routine UGT1A1 Genotyping Before Irinotecan Chemotherapy in Taiwanese Cancer Patients
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Using Sanger sequencing and real-time polymerase chain reaction analysis to study the distribution of UGT1A1 gene in cancer patients in Taiwan. [One month after receiving the samples.]

      After Sanger sequencing and qPCR analysis, we classify several common types, such as UGT1A1*28, UGT1A1*6, and UGT1A1*63. Additionally, we aim to identify whether there are any other mutation points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Colorectal or pancreatic cancer patients.

    Exclusion Criteria:

    Age less than 20 or greater than 90.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05792943
    Other Study ID Numbers:
    • 202209008RINB
    First Posted:
    Mar 31, 2023
    Last Update Posted:
    Mar 31, 2023
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 31, 2023