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UGT1A1 Genotyping in Taiwanese Cancer Patients

Impact of Routine UGT1A1 Genotyping Before Irinotecan Chemotherapy in Taiwanese Cancer Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05792943
Enrollment
100
Registered
2023-03-31
Start date
2023-05-31
Completion date
2024-12-31
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Influence of the UGT1A1 Genotype

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 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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Colorectal or pancreatic cancer patients.

Exclusion criteria

Age less than 20 or greater than 90.

Design outcomes

Primary

MeasureTime frameDescription
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.

Contacts

Primary ContactCHIA SHENG CHANG, Master
smile755101@gmail.com02-23220322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026