UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018541
Receipt number R000021450
Scientific Title A comprehensive, retrospective study of gastrointestinal diseases and associated factors using medical records at Toyoshima Endoscopy Clinic
Date of disclosure of the study information 2015/08/04
Last modified on 2019/09/10 10:08:57

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Basic information

Public title

A comprehensive, retrospective study of gastrointestinal diseases and associated factors using medical records at Toyoshima Endoscopy Clinic

Acronym

A comprehensive, retrospective study of gastrointestinal diseases and associated factors using medical records at Toyoshima Endoscopy Clinic

Scientific Title

A comprehensive, retrospective study of gastrointestinal diseases and associated factors using medical records at Toyoshima Endoscopy Clinic

Scientific Title:Acronym

A comprehensive, retrospective study of gastrointestinal diseases and associated factors using medical records at Toyoshima Endoscopy Clinic

Region

Japan


Condition

Condition

Gastrointestinal diseases, including esophageal, gastric, and colorectal cancer

Classification by specialty

Medicine in general Gastroenterology Endocrinology and Metabolism
Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate and investigate the relationship between disease risk factors, treatment methods, outcome and prognosis, appropriate endoscopic procedures, and gastrointestinal diseases, including esophageal, gastric, and colorectal cancer and corresponding risk factors (age, gender, past medical history, family medical history, disease, findings, treatment) via a statistical method using data on medical treatments performed at Toyoshima Endoscopy Clinic

Basic objectives2

Others

Basic objectives -Others

Retrospective assessment using data on medical treatments performed at Toyoshima Endoscopy Clinic

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The relationship between gastrointestinal diseases, including esophageal, gastric, and colorectal cancer, and corresponding risk factors (age, gender, past medical history, family medical history, disease, findings, treatment)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who received medical care at Toyoshima Endoscopy Clinic during the period from February 1, 2002 to August 2019 will be included

Key exclusion criteria

None

Target sample size

25000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Toyoshima

Organization

Toyoshima Endoscopy Clinic

Division name

President and CEO

Zip code


Address

6-17-5 Seijo, Setagaya-ku Tokyo, Japan

TEL

+81-3-5429-9555

Email

t@ichou.com


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Toyoshima

Organization

Toyoshima Endoscopy Clinic

Division name

President and CEO

Zip code


Address

6-17-5 Seijo, Setagaya-ku Tokyo, Japan

TEL

+81-3-5429-9555

Homepage URL


Email

t@ichou.com


Sponsor or person

Institute

Toyoshima Endoscopy Clinic

Institute

Department

Personal name



Funding Source

Organization

Self-funded

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


Address


Tel


Email



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

とよしま内視鏡クリニック(東京)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 04 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

No longer recruiting

Date of protocol fixation

2015 Year 05 Month 29 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The relationship between gastrointestinal diseases, including esophageal, gastric, and colorectal cancer, and corresponding risk factors (age, gender, past medical history, family medical history, disease, findings, treatment)

Retrospective study


Management information

Registered date

2015 Year 08 Month 04 Day

Last modified on

2019 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name