UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035134
Receipt number R000040041
Scientific Title Prospective observational study of endoscopic resection for early gastrointestinal neoplasms
Date of disclosure of the study information 2019/01/01
Last modified on 2019/04/02 16:33:48

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Basic information

Public title

Prospective observational study of endoscopic resection for early gastrointestinal neoplasms

Acronym

KEIO-GI study

Scientific Title

Prospective observational study of endoscopic resection for early gastrointestinal neoplasms

Scientific Title:Acronym

KEIO-GI study

Region

Japan


Condition

Condition

Early gastrointestinal neoplasms

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the feasibility of endoscopic resection for early gastrointestinal neoplasms

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Five-year relapse-free survival rate

Key secondary outcomes

Procedure success rate, En bloc resection rate, Pathological diagnosis, Complications, Procedure time, Amount of bleeding, Three-year relapse-free survival rate, Relapse-free survival time, Three or five-year overall survival rate, Quality of life after procedure, Medical care cost


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo endoscopic resection for early gastrointestinal neoplasms

Key exclusion criteria

Patients whose lesions were found to be outside the adaptation for endoscopic resection

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name Kato
Middle name
Last name Motohiko

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3437

Email

motohikokato@keio.jp


Public contact

Name of contact person

1st name Kiguchi
Middle name
Last name Yoshiyuki

Organization

Keio University School of Medicine

Division name

Division of Research and Development for Minimally Invasive Treatment, Cancer Center

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3437

Homepage URL


Email

kiguchiyoshiyuki@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Research ethics committee, Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

0333531211

Email

med-rinri-jimu@adst.keio.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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 01 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

2018 Year 11 Month 19 Day

Date of IRB

2018 Year 12 Month 12 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2029 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: Prospective observational study
Aim: To clarify the feasibility of endoscopic resection for early gastrointestinal neoplasms


Management information

Registered date

2018 Year 12 Month 04 Day

Last modified on

2019 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040041


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name