UMIN-CTR Clinical Trial

Basic information
Public title	Clinicopathological differences between right and left-sided T1 colorectal cancer
Acronym	Clinicopathological differences between right and left-sided T1 colorectal cancer
Scientific Title	Clinicopathological differences between right and left-sided T1 colorectal cancer
Scientific Title:Acronym	Clinicopathological differences between right and left-sided 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 right- and left-sided 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 surgical resection with lymph node dissection
Key exclusion criteria	Cases of familial adenomatous polyposis, Lynch syndrome, ulcerative colitis, synchronous invasive carcinoma
Target sample size	750

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Mochizuki
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	k.mochizuki@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Kenichi Middle name Last name Mochizuki
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	k.mochizuki@med.showa-u.ac.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	k.mochizuki@med.showa-u.ac.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	2018 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s00384-020-03668-x
Number of participants that the trial has enrolled	1142
Results	Left-sided T1 colorectal cancer(CRC) showed significantly higher rates of lymph node metastasis(LNM; left-sided 12.0% vs. right-sided 5.4%, P < 0.05) and lymphatic invasion (left-sided 32.7% vs. right-sided 23.2%, P < 0.05). Especially, the sigmoid colon and rectum showed higher rates of LNM than other locations. Patients with left-sided T1 CRC were younger than those with right-sided T1 CRC , as well as significantly lower rates of poorly differentiated carcinoma/mucinous carcinoma than right-sided T1 CRC.
Results date posted	2020 Year 12 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 06 Month 16 Day
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 03 Month 30 Day
Date of IRB	2018 Year 03 Month 20 Day
Anticipated trial start date	2018 Year 03 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Subjects were 1,142 cases with T1 CRCs undergoing surgical resection with lymph node dissection at Showa University Northern Yokohama Hospital. Of these, 366 cases were right-sided (cecum to transverse colon), and 776 cases were left-sided (descending colon to rectum). Analyzed 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.

Management information
Registered date	2018 Year 05 Month 27 Day
Last modified on	2020 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037230