UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056796 |
|---|---|
| Receipt number | R000064916 |
| Scientific Title | Pancreatic Biliary Cancer Cohort study |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/01/23 15:14:08 |
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Basic information
Public title
Pancreatic Biliary Cancer Cohort study
Acronym
PBCC
Scientific Title
Pancreatic Biliary Cancer Cohort study
Scientific Title:Acronym
PBCC
Region
| Japan |
Condition
Condition
Pancreatic cancer, Biriary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We will prospectively follow up the treatment efficacy and prognosis of patients with unresectable cholangiopancreatic cancer by stage, blood test data, and imaging test data to clarify the effect of new drugs on prognosis and analyze the factors involved in prognosis prolongation. We will also conduct genetic analysis research using tumor and blood samples collected during diagnosis and treatment, and contribute to the improvement of the prognosis of cholangiopancreatic cancer treatment by clarifying the pathophysiology of the disease.
Basic objectives2
Others
Basic objectives -Others
We will prospectively follow up the treatment efficacy and prognosis of patients with unresectable cholangiopancreatic cancer by stage, blood test data, and imaging test data to clarify the effect of new drugs on prognosis and analyze the factors involved in prognosis prolongation. We will also conduct genetic analysis research using tumor and blood samples collected during diagnosis and treatment, and contribute to the improvement of the prognosis of cholangiopancreatic cancer treatment by clarifying the pathophysiology of the disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival, progression-free survival, and disease control rate per treatment
Key secondary outcomes
Examination of prognosis-related factors
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients treated for biliopancreatic cancer at Yamanashi Prefectural Central Hospital and the collaborating institutions between the date of approval by the head of the research institution and December 31, 2027.
(2) Target disease: pancreatic cancer, biliary tract cancer
(3) Age: 18 years and older
(4) Gender: Any gender
(5) Patients who have been explained about this study and have obtained a consent form for this study.
Key exclusion criteria
Patients who fall under any one of the following will be excluded from the study.
(1) Patients who have refused to participate in this study.
(2) Patients who are deemed inappropriate as research subjects by the investigators, etc.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Hirose |
Organization
Yamanashi Prefectural Central Hospital
Division name
Gastroenterology Department
Zip code
400-8506
Address
1-1-1 Fujimi, Kofu City, Yamanashi Prefecture, 400-8506, Japan
TEL
0552537111
chubyo@ych.pref.yamanashi.jp
Public contact
Name of contact person
| 1st name | Sumio |
| Middle name | |
| Last name | Hirose |
Organization
Yamanashi Prefectural Central Hospital
Division name
Gastroenterology Department
Zip code
400-8506
Address
1-1-1 Fujimi, Kofu City, Yamanashi Prefecture, 400-8506, Japan
TEL
0552537111
Homepage URL
chubyo@ych.pref.yamanashi.jp
Sponsor or person
Institute
Yamanashi Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
No research funding organization exists
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
Yamanashi Prefectural Central Hospital Ethics Committee
Address
1-1-1 Fujimi, Kofu City, Yamanashi Prefecture, 400-8506, Japan
Tel
0552537111
chubyo@ych.pref.yamanashi.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 | 02 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Patients with a confirmed diagnosis of biliary tract cancer or pancreatic cancer at this hospital or at a collaborating research institute, who have given an explanation based on the attached explanatory document and who have given written consent to participate in this study in full, will be considered eligible, and their medical information will be obtained and registered in REDCap. (2) In addition to biopsy specimens obtained for pathological diagnosis and pathological specimens obtained in surgery for treatment purposes, samples obtained by collecting 10 ml of blood during routine medical examinations and an additional 5 ml of blood for research purposes will be anonymized and stored by assigning an identification code unrelated to the research subjects' personal information. (3) Anonymized samples will be analyzed using a cholangiopancreatic cancer panel (60 genes, 280,220 bp, in-house generated and operated) targeting driver genes (Significantly Mutated Genes) that are frequently identified in cholangiopancreatic cancer in reports by TCGA and others, to identify carcinogenesis-related mutations and therapeutic target genes. (4) For each of the primary endpoints (4) We will examine prognosis by treatment and stage as per the primary endpoints, but we will also add genomic information to extract differences in prognosis depending on the presence or absence of the analyzed gene mutations and the associated factors in long-term survivors.
Management information
Registered date
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064916
