UMIN-CTR Clinical Trial

Basic information
Public title	Clinicopathological differences between small and large T1 colorectal cancer
Acronym	Clinicopathological differences between small and large T1 colorectal cancer
Scientific Title	Clinicopathological differences between small and large T1 colorectal cancer
Scientific Title:Acronym	Clinicopathological differences between small and large T1 colorectal cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of the present study is to compare the clinicopathological features of small and large T1 colorectal cancers.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinicopathological features included patient age, sex, initial treatment, tumor size, morphology, invasion depth, histological grade, lymphatic invasion, vascular invasion, tumor budding, and lymph node metastasis.
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	T1 colorectal cancers undergoing surgicaland endoscopic resection
Key exclusion criteria	Cases of familial adenomatous polyposis, Lynch syndrome, ulcerative colitis, synchronous invasive carcinoma
Target sample size	1150

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Takashina
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL	0459497000
Email	y_takashina2011@yahoo.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Takashina
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL	0459497000
Homepage URL
Email	y_takashina2011@yahoo.co.jp

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

Funding Source
Organization	Nothing
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	Institutional Review Board in Showa University Northern Yokohama Hospital,
Address	35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
Tel	0459497000
Email	y_takashina2011@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	昭和大学横浜市北部病院　消化器センター

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 16 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1150
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	2019 Year 12 Month 18 Day
Date of IRB	2020 Year 01 Month 07 Day
Anticipated trial start date	2020 Year 01 Month 07 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The subjects were 1,152 patients with colorectal T1 cancer who underwent endoscopic or surgical resection at our center. Of these, 116 were small T1 cancers (<10mm) and 1036 were large T1 cancers (>10mm). The clinicopathological characteristics (age, sex, tumor size, gross type, SM invasiveness, histological type, lymphatic invasion, venous invasion, grouping, lymph node metastasis, and initial treatment) were compared between the two groups.

Management information
Registered date	2021 Year 04 Month 14 Day
Last modified on	2021 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050152