UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046824 |
|---|---|
| Receipt number | R000053366 |
| Scientific Title | A Multicenter retrospective study to investigate the clinical significance of "suspicious for malignancy" on peritoneal washing cytology in resected pancreatic cancer |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2023/02/03 09:09:09 |
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Basic information
Public title
A Multicenter retrospective study to investigate the clinical significance of "suspicious for malignancy" on peritoneal washing cytology in resected pancreatic cancer
Acronym
A Multicenter retrospective study to investigate the clinical significance of "suspicious for malignancy" on peritoneal washing cytology in resected pancreatic cancer
Scientific Title
A Multicenter retrospective study to investigate the clinical significance of "suspicious for malignancy" on peritoneal washing cytology in resected pancreatic cancer
Scientific Title:Acronym
A Multicenter retrospective study to investigate the clinical significance of "suspicious for malignancy" on peritoneal washing cytology in resected pancreatic cancer
Region
| Japan |
Condition
Condition
Patients diagnosed with resectable (R) or borderline resectable (BR) pancreatic cancer according to the General Rules for the Study of Pancreatic Cancer 7th edition written by Japan Pancreas Society, who performed upfront surgery, and diagnosed as suspicious or Class III (difficult to differentiate), Class IV (suspicious of malignancy), or Class V (positive/malignant) by peritoneal washing cytology on laparotomy.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical significance, especially the prognosis of patients with resected pancreatic cancer diagnosed as suspicious-positive, Class III and Class IV (suspicious for malignancy) by peritoneal washing cytology, compared to those diagnosed as Class V (positive/malignant) .
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
Progression-free survival, presence of recurrence, first recurrence form
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with resected pancreatic cancer diagnosed as suspicious-positive, Class III and Class IV (suspicious for malignancy) by peritoneal washing cytology
Key exclusion criteria
Patients who underwent neoadjuvant treatment
Patients who have not undergone peritoneal washing cytology
Patients with negative, Class I or II results on peritoneal washing cytology
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Fujii |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
Department of Surgery and Science
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama, Japan
TEL
076-434-7331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Shibuya |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
Department of Surgery and Science
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama, Japan
TEL
076-434-7331
Homepage URL
shibuyak@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
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
Center for Clinical Research, Toyama University Hospital
Address
2630 sugitani, Toyama city, Toyama, Japan
Tel
076-415-8857
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
| 2022 | Year | 02 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Multicenter retrospective study to investigate the clinical significance of "suspicious for malignancy" on peritoneal washing cytology in resected pancreatic cancer
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053366
