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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032477
Receipt No. R000037034
Scientific Title Observational study of pancreatic cancer patients with positive peritoneal lavage cytology
Date of disclosure of the study information 2018/05/07
Last modified on 2020/05/24

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Basic information
Public title Observational study of pancreatic cancer patients with positive peritoneal lavage cytology
Acronym CY1 study
Scientific Title Observational study of pancreatic cancer patients with positive peritoneal lavage cytology
Scientific Title:Acronym CY1 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 To clarify the treatment and outcome in the pancreatic cancer patients with positive peritoneal lavage cytology
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed as peritoneal lavage cytology positive (CY1) by laparotomy or laparoscopy between 1st January 2007 and 12th 31st December 2015 and not having non-curative resection factors
Key exclusion criteria Patients with active cancer or serious complications
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Fukutomi
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Email a.fukutomi@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Todaka
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Homepage URL
Email a.todaka@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Shizuoka Cancer Center Medical
Fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 05 Month 07 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 Main results already published
Date of protocol fixation
2018 Year 01 Month 24 Day
Date of IRB
2018 Year 02 Month 05 Day
Anticipated trial start date
2018 Year 05 Month 07 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information patient characteristics, data of tumor, data of treatment and outcome

Management information
Registered date
2018 Year 05 Month 06 Day
Last modified on
2020 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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