UMIN-CTR Clinical Trial

Basic information
Public title	The risk factor of recurrence in T1 colorectal cancer
Acronym	The risk factor of recurrence in T1 colorectal cancer
Scientific Title	The risk factor of recurrence in T1 colorectal cancer
Scientific Title:Acronym	The risk factor of recurrence in T1 colorectal cancer
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinicopathological risk factors of recurrence in T1 colorectal cancer.
Basic objectives2	Others
Basic objectives -Others	To investigate the risk factors of recurrence in T1 colorectal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	recurrence
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who received complete treatment for submucosal invasive colorectal cancer with endoscopic resection or surgical resection 2.Written informed consent
Key exclusion criteria	1.Presence of synchronous or metachronous advanced colorectal cancer 2.Patients with inflammatory bowel disease 3.Hereditary colorectal cancer
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Yuta Middle name Last name Kouyama
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL	045-949-7000
Email	kouyuta1101@yahoo.co.jp

Public contact
Name of contact person	1st name Yuta Middle name Last name Kouyama
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL	045-949-7000
Homepage URL
Email	kouyuta1101@yahoo.co.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital Digestive Disease Center
Institute
Department

Funding Source
Organization	Showa University Northern Yokohama Hospital Digestive Disease Center
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	Showa University Northern Yokohama Hospital
Address	35-1, Chigasaki-Chuo Tsuzuki-ku, Yokohama-shi
Tel	0459497000
Email	kouyuta1101@yahoo.co.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	2016 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/29748707/
Number of participants that the trial has enrolled	930
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	Main results already published
Date of protocol fixation	2016 Year 06 Month 01 Day
Date of IRB	2016 Year 09 Month 30 Day
Anticipated trial start date	2016 Year 09 Month 06 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective study

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2021 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027575