UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062095 |
|---|---|
| Receipt number | R000071048 |
| Scientific Title | A Prospective Cohort Study to Identify Prognostic Factors in Patients with Resectable and Borderline Resectable Pancreatic Cancer |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/06/29 20:15:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective Observational Study of Resectable and Borderline Resectable Pancreatic Cancer
Acronym
R/BR-PC Study
Scientific Title
A Prospective Cohort Study to Identify Prognostic Factors in Patients with Resectable and Borderline Resectable Pancreatic Cancer
Scientific Title:Acronym
R/BR-PC Study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective observational study is to enroll patients with resectable (R) and borderline resectable (BR) pancreatic cancer before treatment initiation and to collect real-world clinical data throughout neoadjuvant therapy, surgery, postoperative course, and long-term follow-up. The study aims to identify prognostic factors associated with clinical outcomes, including patients who do not undergo surgery because of disease progression or treatment-related adverse events during neoadjuvant therapy, thereby providing evidence that reflects real-world clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival, portoperative complications
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically or radiologically diagnosed pancreatic cancer.
2. Resectable or borderline resectable pancreatic cancer according to the 8th edition of the General Rules for the Study of Pancreatic Cancer, based on contrast-enhanced abdominal CT findings.
3. Scheduled to undergo curative-intent surgical resection for pancreatic cancer.
4. Age 20 years or more at the time of study enrollment.
Key exclusion criteria
1. Patients with psychiatric disorders or symptoms that impair activities of daily living and are considered unsuitable for participation in the study.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Kyoto University Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757513242
ykspirit@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yamane |
Organization
Kyoto University Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757513242
Homepage URL
ykspirit@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-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 | 07 | Month | 20 | 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
| 2026 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2036 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071048
