Exploratory study on biomarkers for chemotherapy resistance in unresectable or recurrent biliary tract cancer using whole genome analysis (KHBO2201-1B)

Exploratory study on biomarkers for chemotherapy resistance in unresectable or recurrent biliary tract cancer using whole genome analysis (KHBO2201-1B) - Exploratory study on biomarkers in biliary tract cancer using whole genome analysis (KHBO2201-1B)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059648

Enrollment

100

Registered

2025-11-05

Start date

2025-11-05

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

unresectable or recurrent biliary tract cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Identification of novel biomarkers	—

Countries

Japan

Contacts

Public ContactToshio Kokuryo

Nagoya University Graduate School of Medicine Division of Surgical Oncology

kokuryo.toshio.f8@f.mail.nagoya-u.ac.jp052-744-2222

Outcome results