Tokyo, Nov. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059648) titled 'Exploratory study on biomarkers for chemotherapy resistance in unresectable or recurrent biliary tract cancer using whole genome analysis (KHBO2201-1B)' on Nov. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Nagoya University
Condition:
Condition - unresectable or recurrent biliary tract cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To elucidate the molecular biological characteristics of biliary tract cancer and identify novel biomarkers associated with chemotherapy responsiveness on it, whole genome analysis is conducted using specimens from patients with unresectable or recurrent biliary tract cancer enrolled in a randomized controlled phase III trial (KHBO-2201 study) comparing gemcitabine/cisplatin/S-1 therapy versus gemcitabine/cisplatin/immune checkpoint inhibitor therapy for unresectable or recurrent biliary tract cancer.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients enrolled in the KHBO-2201 study (a randomized controlled phase III trial comparing gemcitabine/cisplatin/S-1 therapy versus gemcitabine/cisplatin/immune checkpoint inhibitor therapy for unresectable or recurrent biliary tract cancer) , who consented to this study and meet any of the following criteria:
1. Patients whose tissue specimens and peripheral blood specimens are obtained through surgery or examinations conducted at Nagoya University Hospital and collaborative research institutions, are available from the approval date until March 31, 2027, and are suitable for genomic analysis
2. Cases whose frozen existing tissue specimens and peripheral blood specimens were obtained through surgery or examinations conducted at Nagoya University Hospital and collaborative research institutions since April 1, 2015, are available, can be confirmed alive and contactable until March 31, 2027, and whose specimens are suitable for submission for genomic analysis
3. Patients participating in the research study 'Gene profiling of cholangiocarcinoma concerning the sensitivity of anti-cancer drugs' (Approval Number: 2016-02688716) or 'Analysis of the regulatory system concerning the telomere instability in several diseases, such as malignant tumor, lifestyle related disease, viral hepatitis, hematologic disease, neurodegenerative disorder or mental disorders' (Approval Number: 2016-02748747)
Key exclusion criteria - 1. Cases with inadequate or insufficient tissue specimens and peripheral blood specimens suitable for the study
2. Cases deemed ineligible at the investigator's or co-investigator's discretion
3. Cases who declined to participate or failed to provide informed consent for the study
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 01 Day
Anticipated trial start date - 2025 Year 11 Month 05 Day
Last follow-up date - 2031 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067371
Disclaimer: Curated by HT Syndication.
