UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058615 |
|---|---|
| Receipt number | R000066929 |
| Scientific Title | Exploration of novel biomarker for the eligibility of neoadjuvant chemotherapy followed by operation for the patient with biliary pancreatic cancer |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/07/28 14:35:34 |
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Basic information
Public title
Exploration of novel biomarker for the eligibility of neoadjuvant chemotherapy followed by operation for the patient with biliary pancreatic cancer
Acronym
Biliary-Pancreatic cancer preoperative treatment outcome biomarker exploration study: B-PROBE study
Scientific Title
Exploration of novel biomarker for the eligibility of neoadjuvant chemotherapy followed by operation for the patient with biliary pancreatic cancer
Scientific Title:Acronym
Biliary-pancreatic cancer preoperative treatment outcome biomarker exploration study: B-PROBE study
Region
| Japan |
Condition
Condition
pancreatic cancer,bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Multimodal treatment strategies for pancreatic and biliary tract cancers have yet to be fully established. This study aims to comprehensively investigate prognostic factors that influence the resectability and survival outcomes of neoadjuvant chemotherapy (NAC) followed by surgery. We will evaluate therapeutic approaches from the perspectives of drug-related, tumor-related, and host-related factors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the associations between drug-related, tumor-related, and host-related factors and the therapeutic response to multimodal treatment.
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
Eligible patients must (1) be of any sex, (2) be at least 20 years old at the time of consent, and (3) have received a full explanation of the study, understood its content, and voluntarily signed a written informed consent form.
Key exclusion criteria
Exclusion criteria include: (1) ECOG Performance Status of 3 or 4, (2) diagnosis of dementia, and (3) any case in which the investigator or sub-investigator determines the patient to be inappropriate for study enrollment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi university graduate school of medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
TEL
0836222264
geka2dm@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Nakajima |
Organization
Yamaguchi university graduate school of medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
TEL
0836222264
Homepage URL
geka2dm@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minamikogushi Ube-shi, Yamaguchi-ken
Tel
0836222428
clin_res@yamaguchi-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
山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066929
