UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter study of acinar cell carcinoma in Japan
Acronym	Multicenter study of acinar cell carcinoma
Scientific Title	Multicenter study of acinar cell carcinoma in Japan
Scientific Title:Acronym	Multicenter study of acinar cell carcinoma
Region	Japan

Condition
Condition	acinar cell carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the clinic-pathologic features of patients with acinar cell carcinoma
Basic objectives2	Others
Basic objectives -Others	To reveal the pathological grading of acinar cell carcinoma
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To reveal the clinic-pathologic features of patients with acinar cell carcinoma
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	1 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patients with acinar cell carcinoma diagnosed histologically by resection or EUS-FNA between January 2000 and December 2020
Key exclusion criteria	The cases without component of acinar cell carcinoma The cases without histlogical diagnosis
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Kanno
Organization	Jichi Medical University
Division name	Department of Medicine, Division of Gastroenterology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL	0285-58-7348
Email	atsushih@jichi.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Kanno
Organization	Jichi Medical University
Division name	Department of Medicine, Division of Gastroenterology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
TEL	0285-58-7348
Homepage URL
Email	atsushih@jichi.ac.jp

Sponsor
Institute	Japan Pancreas Society
Institute
Department

Funding Source
Organization	Japan Pancreas Society
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	Support Center for Clinical Investigation, Jichi Medical University
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan
Tel	0285-58-8933
Email	rinri@jichi.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	2021 Year 09 Month 21 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	Enrolling by invitation
Date of protocol fixation	2021 Year 04 Month 08 Day
Date of IRB	2021 Year 05 Month 07 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2026 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This was a retrospective, observational study that examined the clinic-pathologic features of patients with acinar cell carcinoma diagnosed between January 2000 and December 2020.

Management information
Registered date	2021 Year 09 Month 21 Day
Last modified on	2021 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051991