UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053955 |
|---|---|
| Receipt number | R000061583 |
| Scientific Title | Predictive factors for early recurrence in patients with borderline resectable pancreatic cancer undergoing curative resection after neoadjuvant therapy |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/09/22 12:52:07 |
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Basic information
Public title
Predictive factors for early recurrence in patients with borderline resectable pancreatic cancer undergoing resection after neoadjuvant therapy
Acronym
Predictive factors for early recurrence in borderline resectable pancreatic cancer undergoing resection after neoadjuvant therapy
Scientific Title
Predictive factors for early recurrence in patients with borderline resectable pancreatic cancer undergoing curative resection after neoadjuvant therapy
Scientific Title:Acronym
Predictive factors for early recurrence in borderline resectable pancreatic cancer undergoing resection after neoadjuvant 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 identify predictive factors for early recurrence in patients with borderline resectable pancreatic cancer undergoing curative resection after neoadjuvant therapy
Basic objectives2
Others
Basic objectives -Others
To identify predictive factors for early recurrence in patients with borderline resectable pancreatic cancer undergoing curative resection after neoadjuvant therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify predictive factors for early recurrence in patients with borderline resectable pancreatic cancer undergoing curative resection after neoadjuvant therapy
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
(1) Patients who received pathological diagnosis of pancreatic cancer including ductal adenocarcinoma or adenosquamous carcinoma
(2) Patients categorized as borderline resectable before the initiation of neoadjuvant treatment
(3) Patients undergoing curative-intent resection after neoadjuvant therapy
Key exclusion criteria
(1) Patients in whom final pathological diagnosis is not pancreatic cancer including ductal adenocarcinoma or adenosquamous carcinoma
(2) Patients who had locally-advanced or unresectable factors on preoperative imaging findings
(3) Patients who had locally-advanced or unresectable factors in intra-operative findings
(4) Patients who died of postoperative complications
(5) Patients judged ineligible for the study by the research representative
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Graduate School of Medicine, Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantion, Department of Surgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4323
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Nagai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantion, Department of Surgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4323
Homepage URL
kaznagai@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
075-753-4680
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
| 2024 | Year | 05 | 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
158
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
| 2024 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi-institutional retrospective observational study
Management information
Registered date
| 2024 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061583
