UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054904 |
|---|---|
| Receipt number | R000062728 |
| Scientific Title | The clinical pathological significance in cases of pancreatic cancer that achieved pathological complete response after preoperative therapy: the retrospective study |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/06 21:47:34 |
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Basic information
Public title
The clinical pathological significance in cases of pancreatic cancer that achieved pathological complete response after preoperative therapy: the retrospective study
Acronym
The retrospective study of pancreatic cancer cases that achieved pathological complete response with preoperative therapy.
Scientific Title
The clinical pathological significance in cases of pancreatic cancer that achieved pathological complete response after preoperative therapy: the retrospective study
Scientific Title:Acronym
The retrospective study of pancreatic cancer cases that achieved pathological complete response with preoperative therapy.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the oncological prognosis and clinicopathological characteristics of pancreatic cancer cases that achieved pathological complete response with preoperative therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Relapse free survival
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
1) A pathological diagnosis of pancreatic cancer (invasive ductal carcinoma of the pancreas) has been obtained before the start of treatment.
2) Preoperative chemotherapy or chemoradiotherapy has been administered. The regimen and duration of administration are not specified.
3) Curative resection has been performed, and no residual cancer is observed in the resected specimen upon pathological examination (pathological complete response, pCR: Histological Effect Judgment Grade 4 according to the General Rules for the Study of Pancreatic Cancer / Evans classification Grade IV / CAP score 0). However, residual PanIN (including high-grade PanIN [so-called carcinoma in situ]) is included in pCR (considered eligible).
4) At the time of diagnosis, the resectability classification is R, BR-PV, BR-A, or UR-LA (according to the 8th edition of the General Rules for the Study of Pancreatic Cancer).
Key exclusion criteria
1) Cases in which distant metastasis was observed before the start of treatment or during preoperative therapy.
2) Cases in which distant metastasis (liver metastasis, peritoneal dissemination, positive peritoneal lavage cytology) was observed during intraoperative findings.
3) Cases in which residual cancer was present at the time of surgery (R2 resection).
4) Cases where the patient died due to postoperative complications.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Graduate School of Medicine and Faculty of Medicine Kyoto University
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
0757514323
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yamane |
Organization
Graduate School of Medicine and Faculty of Medicine Kyoto University
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
0757514323
Homepage URL
ykspirit@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
0757534680
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | 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
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the oncological prognosis and clinicopathological characteristics of pancreatic cancer cases that achieved pathological complete response (pCR) with preoperative therapy.
Management information
Registered date
| 2024 | Year | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062728
