UMIN-CTR Clinical Trial

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