UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045535
Receipt number R000051991
Scientific Title Multicenter study of acinar cell carcinoma in Japan
Date of disclosure of the study information 2021/09/21
Last modified on 2021/09/21 22:59:03

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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 or person

Institute

Japan Pancreas Society

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051991


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name