UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052109 |
|---|---|
| Receipt number | R000059442 |
| Scientific Title | The effect of adjuvant chemotherapy on the prognosis in the patients with familial pancreatic cancer (JON2201-P) |
| Date of disclosure of the study information | 2023/09/06 |
| Last modified on | 2025/03/08 14:53:37 |
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Basic information
Public title
The effect of adjuvant chemotherapy on the prognosis in the patients with familial pancreatic cancer (JON2201-P)
Acronym
The effect of adjuvant chemotherapy on the prognosis in the patients with familial pancreatic cancer (JON2201-P)
Scientific Title
The effect of adjuvant chemotherapy on the prognosis in the patients with familial pancreatic cancer (JON2201-P)
Scientific Title:Acronym
The effect of adjuvant chemotherapy on the prognosis in the patients with familial pancreatic cancer (JON2201-P)
Region
| Japan |
Condition
Condition
Pancreatic cancer treated with postoperative adjuvant chemotherapy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of postoperative adjuvant chemotherapy for patients with familial pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative recurrence-free survival period
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 underwent curative resection for primary pancreatic cancer between January 2013 and December 2019 at research collaborate facilities
Familial pancreatic cancer patient group: Have a family history of pancreatic cancer in a first-degree relative (parent, sibling, children)
Non-familial pancreatic cancer patient group: No family history of pancreatic cancer in first-degree relatives (parents, siblings, children)
Key exclusion criteria
1. Patients with preoperative chemotherapy (neoadjuvant chemotherapy or neoadjuvant chemo-radiotherapy)
2. Patients who have not undergone R0 or R1 resection
3. Histological types other than pancreatic ductal cancer
4. Patients who have not been treated by postoperative adjuvant chemotherapy
5. Patients who have opted out and have been refused access to medical information by research subjects or their familiy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yukiyasu |
| Middle name | |
| Last name | Okamura |
Organization
Nihon University Faculty of Medicine
Division name
Division of Digestive Surgery, Department of Surgery
Zip code
173-8610
Address
30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
okamura.yukiyasu@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Miura |
Organization
Shizuoka Cancer Center
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Sunto-Nagaizumi, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
https://jon-hbp.org/rinsho/
yu.miura@scchr.jp
Sponsor or person
Institute
Japan Oncology Network in Hepatobiliary and Pancreas (JON-HBP)
Institute
Department
Personal name
Funding Source
Organization
Japan Oncology Network in Hepatobiliary and Pancreas (JON-HBP)
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
Nihon University Itabashi Hospital Certified Clinical Research Review Board
Address
30-1, Oyaguchikami-machi, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
med.rinsyokenkyu@nihon-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
| 2023 | Year | 09 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Non-familial pancreatic cancer patient group>
Patient background factors: date of birth, gender, history of cancer (if present, kind of cancer)
Tumor factors: pancreatic cancer occupied site (head/body/tail), pancreatic cancer resectability classification, resection specimen evaluation (pathological UICC-TNM classification, tumor diameter, tumor differentiation, presence or absence of serosa invasion, presence or absence of portal vein invasion, presence or absence of nerve infiltration, degree of curative resection), peritoneal lavage cytology
Blood test findings: preoperative CA19-9 value, CA19-9 value before postoperative adjuvant chemotherapy
Treatment information: surgery date, surgical method, amount of blood loss, surgery time, presence or absence of intraoperative blood transfusion, postoperative adjuvant chemotherapy regimen, postoperative adjuvant chemotherapy start date, final day of postoperative adjuvant chemotherapy (in the case of oral medication: the day of final prescription)
Therapeutic effect: the final recurrence-free survival confirmation date, the presence or absence of recurrence or death at that time, and the site of recurrence
Post-treatment: presence or absence of post-recurrence treatment, use of platinum-based anticancer drugs in post-recurrence treatment (if yes, details of regimen)
Prognosis: Presence or absence of survival, date of final confirmation of survival
<Familial pancreatic cancer patient group>
Familial pancreatic cancer patients: In addition to the collection items for non-familial pancreatic cancer patients, which first-degree relatives (parents, siblings, children) had pancreatic cancer, and the number of first-degree relatives with pancreatic cancer.
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059442
