UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058081 |
|---|---|
| Receipt number | R000066045 |
| Scientific Title | A nationwide multi-institutional retrospective study to investigate predictors of positive peritoneal cytology in pancreatic Cancer |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/05/08 22:22:18 |
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Basic information
Public title
A nationwide multi-institutional retrospective study to investigate predictors of positive peritoneal cytology in pancreatic Cancer
-A project study of Japan Pancreas Society-
Acronym
CYCLONE study
Scientific Title
A nationwide multi-institutional retrospective study to investigate predictors of positive peritoneal cytology in pancreatic Cancer
Scientific Title:Acronym
CYCLONE study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the relationship between peritonial cytology(CY) positivity and clinicopathologic factors such as pretreatment laboratory tests and resectability classification in pancreatic cancer, and to identify predictive factors for CY positivity.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the percentage of positive cytology results per resectability category for pancreatic cancer among patients who underwent peritonial cytology.
Key secondary outcomes
Predictors of positive peritonial cytology.
Factors involved in the negative results of positive peritonial cytology.
Recurrence-free survival rate, cumulative recurrence rate, overall survival rate, site of recurrence, and form of recurrence after resection of the primary tumor.
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
1) Patients with pancreatic cancer who have histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma prior to performing peritonial cytology.
2) Cases in which resectability classification is diagnosed prior to performing peritonial cytology.
3) Cases in which preoperative treatment (chemotherapy, radiation therapy, or combined chemoradiotherapy) has not been introduced prior to performing peritonial cytology.
4) Patients meeting the above criteria who underwent peritonial cytology between January 1, 2017 and December 31, 2024, at the time of the review laparoscopy or at the time of radical resection without preoperative treatment.
Key exclusion criteria
1) Cases with malignant tumors under treatment or diagnosed concurrently at the time of diagnosis of pancreatic cancer (*Endoscopically curatively resected intramucosal carcinoma or basal cell carcinoma or squamous cell carcinoma of the skin may be registered).
2) Cases of residual pancreatic cancer.
3) Cases diagnosed with resectability classification of UR-M before laparoscopy.
4) Cases who refused to participate in this study by opting out.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
University of Toyama
Division name
Department of Surgery and Science, Faculty of Medicine, Academic Assembly
Zip code
930-0152
Address
2630 sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-7331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Itoh |
Organization
University of Toyama
Division name
Department of Surgery and Science, Faculty of Medicine, Academic Assembly
Zip code
930-0152
Address
2630 sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-7331
Homepage URL
aitoh@med.u-toyama.ac.jp
Sponsor or person
Institute
Japan Pancreas Society
Institute
Department
Personal name
Funding Source
Organization
Japan Pancreas Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institution with an advisor affiliated with the Japan Pancreas Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
2630 sugitani, Toyama-shi, Toyama, Japan
Tel
076-434-2315
rinri@adm.u-toyama.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
| 2025 | Year | 10 | Month | 10 | 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
| 2025 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cases in which peritonial cytology was performed at each institution from January 1, 2017 to December 31, 2024 will be included. Clinical data will be collected from electronic medical records to explore peritonial cytology results and clinicopathologic factors.
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066045
