UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter retrospective study of the relationship between colonic diverticulosis and colorectal neoplasms
Acronym	the relationship between colonic diverticulosis and colorectal neoplasms
Scientific Title	Multicenter retrospective study of the relationship between colonic diverticulosis and colorectal neoplasms
Scientific Title:Acronym	the relationship between colonic diverticulosis and colorectal neoplasms
Region	Japan

Condition
Condition	Colonic diverticulosis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the risk factors of colonic diverticulosis and the relationship between colonic diverticulosis and colorectal neoplasms.
Basic objectives2	Others
Basic objectives -Others	Establishment of a new strategy of the clinical management of colonic diseases.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome of this study is to clarify whether colonic diverticulosis is predictor for presence of colorectal neoplasms
Key secondary outcomes	The secondary outcomes were to confirm the predictors of colonic diverticulosis in Japanese patients and to investigate the relationship of location between colonic diverticulosis and colorectal neoplasms

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	16 years-old <=
Age-upper limit	110 years-old >
Gender	Male and Female
Key inclusion criteria	patients with both colonoscopy and EGD
Key exclusion criteria	patients with colectomy
Target sample size	6000

Research contact person
Name of lead principal investigator	1st name Ryotaro Middle name Last name Nakahara
Organization	New Tokyo Hospital
Division name	Gastroenterology
Zip code	270-2232
Address	1271 Wanagaya, Matsudo city, Chiba
TEL	047-711-8700
Email	y-amano@shin-tokyohospital.or.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Amano
Organization	New Tokyo Hospital
Division name	Endoscopy
Zip code	270-2232
Address	1271 Wanagaya, Matsudo city, Chiba
TEL	047-711-8700
Homepage URL
Email	y-amano@shin-tokyohospital.or.jp

Sponsor
Institute	Division of Endoscopy, New Tokyo Hospital
Institute
Department

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	New Tokyo Hospital
Address	1271 Wanagaya, Matsudo, Chiba, Japan
Tel	047-711-8700
Email	y-amano@shin-tokyohospital.or.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	2019 Year 12 Month 25 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	6000
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	Completed
Date of protocol fixation	2018 Year 10 Month 25 Day
Date of IRB	2018 Year 06 Month 07 Day
Anticipated trial start date	2018 Year 10 Month 25 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 04 Month 30 Day

Other
Other related information	the entry will be started after the IRB approval in other enrolled institutions.

Management information
Registered date	2019 Year 12 Month 25 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044453