UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039565
Receipt number R000045118
Scientific Title Investigation of medical trend for Lynch syndrome
Date of disclosure of the study information 2020/02/21
Last modified on 2021/02/21 10:43:26

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Basic information

Public title

Investigation of medical trend for Lynch syndrome in cancer genomics medicine time

Acronym

Investigation of medical trend for Lynch syndrome in cancer genomics medicine time

Scientific Title

Investigation of medical trend for Lynch syndrome

Scientific Title:Acronym

Investigation of medical trend for Lynch syndrome

Region

Japan


Condition

Condition

Lynch symdrome

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

clinical trend surveillance for lynch symdrome

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

changing for clinical trend

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

councilors of the Japanese Society of Gastroenterology

Key exclusion criteria

none

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Tanaka

Organization

Hiroshima University Hospital

Division name

Department of Endoscopy

Zip code

734-8553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima, Japan

TEL

082-257-5538

Email

colon@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Urabe

Organization

Hiroshima University Hospital

Division name

Department of Regeneration and Medicine Medical Center for Translation and Clinical Research

Zip code

734-8553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima, Japan

TEL

082-257-5538

Homepage URL


Email

beyan13@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Endoscopy, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

The Japanese Society of Gastroenterology

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

Hirosima University

Address

1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima, Japan

Tel

082-257-5555

Email

kasumi-kenkyu@office.hiroshima-u.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

2020 Year 02 Month 21 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

362

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

No longer recruiting

Date of protocol fixation

2020 Year 01 Month 31 Day

Date of IRB

2020 Year 01 Month 31 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2020 Year 11 Month 02 Day

Date analysis concluded



Other

Other related information

questionnaire survey


Management information

Registered date

2020 Year 02 Month 21 Day

Last modified on

2021 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045118


Research Plan
Registered date File name
2023/09/15 研究計画書_倫理委員会予備審査後.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2023/09/15 診療動向調査解析202309015_UMINアップロードデータ.xlsx