UMIN-CTR Clinical Trial

Basic information
Public title	Molecular pathological analysis of the occurrence and progress of pancreatic carcinoma in situ using biopsy/pancreatic juice specimen.
Acronym	Analysis of the progress of pancreatic carcinoma in situ.
Scientific Title	Molecular pathological analysis of the occurrence and progress of pancreatic carcinoma in situ using biopsy/pancreatic juice specimen.
Scientific Title:Acronym	Analysis of the progress of pancreatic carcinoma in situ.
Region	Japan

Condition
Condition	Pancreatic carcinoma in situ Small pancreatic ductal adenocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Molecular pathological analysis of the occurrence and progress of pancreatic carcinoma in situ using biopsy/pancreatic juice specimen.
Basic objectives2	Others
Basic objectives -Others	Comparison of pancreatic cancer in situ cell and resected pancreas specimen
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of the molecular pathological factor effecting the progress of pancreatic carcinoma in situ.
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with suspicious pancreatic carcinoma in situ and who undergo pancreatic juice cytology.
Key exclusion criteria	cannot obtain consensus. cannot obtain sufficient pancreatic juice. cannot undergo surgically resection
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Sagami
Organization	Oita University Faculty of Medicine
Division name	Department of Gastroenterology
Zip code	879-5593
Address	1-1 Idaigaoka, Hasamacho, Yufu, Oita 8795593, Japan
TEL	097-549-4411
Email	sagami1985@yahoo.co.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Sagami
Organization	Oita University Faculty of Medicine
Division name	Department of Gastroenterology
Zip code	879-5593
Address	1-1 Idaigaoka, Hasamacho, Yufu, Oita 8795593, Japan
TEL	097-549-4411
Homepage URL
Email	sagami1985@yahoo.co.jp

Sponsor
Institute	Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
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	Oita University Faculty of Medicine
Address	1-1 Idaigaoka, Hasamacho, Yufu, Oita 8795593, Japan
Tel	097-549-4411
Email	sagami1985@yahoo.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2340
Org. issuing International ID_1	Oita University Faculty of Medicine
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 09 Month 14 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	Open public recruiting
Date of protocol fixation	2022 Year 07 Month 25 Day
Date of IRB	2022 Year 07 Month 25 Day
Anticipated trial start date	2022 Year 07 Month 25 Day
Last follow-up date	2027 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 09 Month 14 Day
Last modified on	2022 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055753