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Trial Title:
UGT1A1 Genotyping in Taiwanese Cancer Patients
NCT ID:
NCT05792943
Condition:
The Influence of the UGT1A1 Genotype
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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 UGT1A1*28, but the
common UGT1A1 genotype in Taiwan also has UGT1A1*6 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.
Criteria for eligibility:
Study pop:
The study population of this project is patients with colorectal or pancreatic cancer
from the National Taiwan University Cancer Center. A total of 100 cases are expected to
be enrolled, ranging in age from 20 to 90 years old.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
Colorectal or pancreatic cancer patients.
Exclusion Criteria:
Age less than 20 or greater than 90.
Gender:
All
Minimum age:
20 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
May 2023
Completion date:
December 2024
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05792943
