UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059648 |
|---|---|
| Receipt number | R000067371 |
| Scientific Title | Exploratory study on biomarkers for chemotherapy resistance in unresectable or recurrent biliary tract cancer using whole genome analysis (KHBO2201-1B) |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 17:01:36 |
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Basic information
Public title
Exploratory study on biomarkers for chemotherapy resistance in unresectable or recurrent biliary tract cancer using whole genome analysis (KHBO2201-1B)
Acronym
Exploratory study on biomarkers in biliary tract cancer using whole genome analysis (KHBO2201-1B)
Scientific Title
Exploratory study on biomarkers for chemotherapy resistance in unresectable or recurrent biliary tract cancer using whole genome analysis (KHBO2201-1B)
Scientific Title:Acronym
Exploratory study on biomarkers in biliary tract cancer using whole genome analysis (KHBO2201-1B)
Region
| Japan |
Condition
Condition
unresectable or recurrent biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
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
Basic objectives -Others
To interpret the clinical significance of analysis results through expert panels, provide appropriate return of results to patients, and establish a personalized medicine platform that utilizes the genomic information of each individual patient in clinic. Final goal is contribution to improve diagnostic and therapeutic outcomes for biliary tract cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of novel biomarkers
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Kokuryo |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan.
TEL
052-744-2222
kokuryo.toshio.f8@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Kokuryo |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan.
TEL
052-744-2222
Homepage URL
kokuryo.toshio.f8@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee Nagoya University Graduate School of Medicine /Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan.
Tel
052-744-2479
iga-shinsa@t.mail.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Genomic Information: Whole genome sequence data, RNA sequence information, Somatic mutations, Germline mutations, Structural abnormalities and fusion genes
2. Clinical Information: Basic information: sex, age, height, weight, Past medical history and family history, Laboratory findings (pre- and post-chemotherapy), Imaging findings (CT, MRI, PET), Pathological findings, Treatment details: medications, examinations, etc.
3. Treatment Course and Prognosis: Treatment response, Adverse events and side effects, Recurrence status and timing, Progression-free survival, Overall survival, Last survival confirmation date
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067371
