UMIN-CTR Clinical Trial

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
Institute	Toyoshima Endoscopy Clinic
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021450