UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060141 |
|---|---|
| Receipt number | R000068786 |
| Scientific Title | Diagnostic accuracy of FGFR2 gene alterations in endoscopic transpapillary biopsy specimens of hilar cholangiocarcinoma |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/12/19 22:45:08 |
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Basic information
Public title
Diagnostic accuracy of FGFR2 gene alterations in endoscopic transpapillary biopsy specimens of hilar cholangiocarcinoma
Acronym
Diagnostic accuracy of FGFR2 gene alterations in endoscopic transpapillary biopsy specimens of hilar cholangiocarcinoma
Scientific Title
Diagnostic accuracy of FGFR2 gene alterations in endoscopic transpapillary biopsy specimens of hilar cholangiocarcinoma
Scientific Title:Acronym
Diagnostic accuracy of FGFR2 gene alterations in endoscopic transpapillary biopsy specimens of hilar cholangiocarcinoma
Region
| Japan |
Condition
Condition
Perihilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We evaluated the concordance rate of FGFR2 mutation detection between transpapillary biopsy specimens and surgical specimens in patients with perihilar cholangiocarcinoma.
Basic objectives2
Others
Basic objectives -Others
If FGFR2 gene mutations can be identified in biopsy specimens from patients with perihilar cholangiocarcinoma, this would expand treatment options for chemotherapy, particularly in unresectable cases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We calculated the concordance rate of FGFR2 mutations between surgical specimens and biopsy specimens in patients with perihilar cholangiocarcinoma.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed with cancer by preoperative bile duct biopsy and subsequently underwent surgery at Nagoya University Hospital between January 1, 2015, and July 31, 2025, and who were pathologically confirmed to have perihilar cholangiocarcinoma were included.
Key exclusion criteria
Patients who received preoperative chemotherapy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kawashima |
Organization
Nagoya Univercity Graduate school of medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4660065
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
0527412602
kawashima.hiroki.p5@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Takada |
Organization
Nagoya Univercity Graduate school of medicine
Division name
Department of Clinical Research Education
Zip code
4660065
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
0527442458
Homepage URL
ytakada@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Section
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel
052-744-2423
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
| 2026 | Year | 04 | Month | 01 | 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 | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
before the start of the study
Management information
Registered date
| 2025 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068786
