UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048808 |
|---|---|
| Receipt number | R000055296 |
| Scientific Title | A nationwide retrospective study to clarify the adequate treatment strategy for pancreatic cancer with positive peritoneal cytology |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/08/31 18:40:36 |
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Basic information
Public title
A nationwide retrospective study to clarify the adequate treatment strategy for pancreatic cancer with positive peritoneal cytology
Acronym
A nationwide retrospective study to clarify the adequate treatment strategy for pancreatic cancer with positive peritoneal cytology
Scientific Title
A nationwide retrospective study to clarify the adequate treatment strategy for pancreatic cancer with positive peritoneal cytology
Scientific Title:Acronym
A nationwide retrospective study to clarify the adequate treatment strategy for pancreatic cancer with positive peritoneal cytology
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 study was to clarify the adequate treatment for CY1 pancreatic cancer by comparing the outcomes of surgical resection with those of non-surgical traesament as a treatment for CY1 pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognostic comparison between surgical resection and non-surgical treatment for CY1 pancreatic cancer
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) Disease name: Pancreatic adenocarcinoma (Cases diagnosed histologically or cytologically as pancreatic adenocarcinoma. Class IV is included in cytological diagnosis)
(2) Stage: Patients diagnosed with resectable pancreatic cancer or borderline resectable pancreatic cancer by imaging diagnosis at the time of initial diagnosis and indicated for resection or anticancer drug treatment.
(3) Patients with positive cytological diagnosis by abdominal cavity washing: Patients who were diagnosed as Class IV or V equivalent by Papanicolaou classification.
(4) Patients must be at least 20 years of age (at the time of CY1 diagnosis).
Key exclusion criteria
(1) Patients who have not been diagnosed as pancreatic adenocarcinoma histologically or cytologically
(2) Patients diagnosed with distant metastasis by various imaging tests
(3) Patients with active multiple cancers (synchronous multiple cancers and heterochronic multiple cancers with a disease-free period of 5 years or less) at the time of CY1 diagnosis
(4) Patients diagnosed with Papanicolaou classification Class III or lower by laparoscopic cytology.
(5) Other cases that the investigator(s) deems inappropriate for this study.
Target sample size
766
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Unno |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7205
m_unno@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Ariake |
Organization
Sendai Open Hospital
Division name
Department of Surgery
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai
TEL
022-252-1111
Homepage URL
ariake@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
cirb@rinri.hosp.tohoku.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 | 01 | 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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Retrospective study
Management information
Registered date
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055296
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
