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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039298
Receipt No. R000044766
Scientific Title Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE) for pancreatic carcinoma in situ
Date of disclosure of the study information 2020/01/29
Last modified on 2020/03/27

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Basic information
Public title Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE) for pancreatic carcinoma in situ
Acronym Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE)
Scientific Title Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE) for pancreatic carcinoma in situ
Scientific Title:Acronym Evaluation of the efficacy of serial pancreatic-juice aspiration cytologic examination (SPACE)
Region
Japan

Condition
Condition Pancreatic carcinoma in situ
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We reveal the efficacy of the SPACE for the diagnosis of the pancreatic carcinoma in situ.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The accuracy of pancreatic juice cytology.
Key secondary outcomes The evaluation of the image findings suggesting the pancreatic carcinoma in situ.

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) The pancreatic duct dilation, pancreatic duct stenosis, focal pancreatic atrophy and fatty change either CT, MRI or EUS.
2) Written informed consent.
Key exclusion criteria 1)Unachievable ERCP due to difficult cannulation.
2)Unachievable ERCP due to post-abdominal surgery state including gastrectomy.
3)Inappropriate patients for study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Sawako
Middle name
Last name Kuruma
Organization Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name Department of Gastroenterology
Zip code 113-8677
Address 3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
TEL 03-3823-2101
Email sawako@cick.jp

Public contact
Name of contact person
1st name Sawako
Middle name
Last name Kuruma
Organization Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Division name Department of Gastroenterology
Zip code 113-8677
Address 3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
TEL 03-3823-2101
Homepage URL
Email sawako@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Institute
Department

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 Institutional Review Board, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Address 3-18-22, Honkomagome Bunkyo-ku, Tokyo 113-8677 JAPAN
Tel 03-3823-2101
Email rinri@cick.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 がん・感染症センター都立駒込病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 29 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
2020 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 29 Day
Last follow-up date
2024 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prognosis of pancreatic cancer is poor, but the prognosis is better if diagnosed at the stage of pancreatic carcinoma in situ. We expect the diagnosis of pancreatic carcinoma in situ will improve by serial pancreatic-juice aspiration cytologic examination (SPACE).

Management information
Registered date
2020 Year 01 Month 28 Day
Last modified on
2020 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044766

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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