UMIN-CTR Clinical Trial

Basic information
Public title	Molecular and clinicopathological features of depressed T2 colorectal cancer
Acronym	Molecular and clinicopathological features of depressed T2 colorectal cancer
Scientific Title	Molecular and clinicopathological features of depressed T2 colorectal cancer
Scientific Title:Acronym	Molecular and clinicopathological features of depressed T2 colorectal cancer
Region	Japan

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

Objectives
Narrative objectives1	To review the consensus molecular subtypes and clinicopathological characteristics of depressed colorectal cancer in comparison with protruded colorectal cancer.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Consensus molecular subtypes of depressed colorectal cancer
Key secondary outcomes	Clinicopathological features of depressed colorectal cancer

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 with colorectal cancer who were surgically resected at Showa University Northern Yokohama Hospital between January 2010 and December 2013 and had a pathological depth of T2.
Key exclusion criteria	Cases of patients with Familial Adenomatous Polyposis, cases of patients with Lynch syndrome, cases of patients with ulcerative colitis, cases of patients who received preoperative chemotherapy and radiation therapy, cases of patients with missing clinical data
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Koshi Middle name Last name Mimori
Organization	Kyushu University Beppu Hospital
Division name	Department of Surgery
Zip code	874-0838
Address	4546 Tsurumibara, Beppu, Oita
TEL	0977-27-1600
Email	kyudaibeppu@gmail.com

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, Chigasakichuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL	045-949-7000
Homepage URL
Email	k.mochizuki@med.showa-u.ac.jp

Sponsor
Institute	yushu University Beppu Hospital, Department of Surgery
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Certified institutional Review Board for Clinical Trials
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka, Japan
Tel	092-642-5774
Email	kyudai-rinri@jimu.kyushu-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

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 08 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0273566
Number of participants that the trial has enrolled	55
Results	Consensus Molecular Subtypes (CMS) were searched for a total of 55 colorectal T2 cancers (30 depressed and 25 protruded colorectal cancers) using immunostaining, and 15 cases classified as CMS4 were all depressed colorectal cancers. Malignant pathological findings, such as lymphatic invasion, were more common in depressed than in protruded colorectal cancer cases.
Results date posted	2022 Year 10 Month 21 Day
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	2021 Year 07 Month 14 Day
Date of IRB	2021 Year 07 Month 14 Day
Anticipated trial start date	2021 Year 10 Month 08 Day
Last follow-up date	2021 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

In general, we have been curious to know the extraordinary discrepancy in the depressed colorectal cancer indicating the severe malignant potential despite the small size of tumor. However, due to the rare morbidity, the molecular biological characteristics were elucidated yet. It has been reported that colorectal cancer can be classified into four consensus molecular subtypes (CMS) by analyzing genomic aberrations and gene expression profiles. In this study, we comprehensively evaluate the molecular biological features of depressed T2 colorectal cancer to classify them into the CMS by the established analyzing pipeline using immunostaining findings and further compare them with clinicopathological features.

Management information
Registered date	2021 Year 10 Month 08 Day
Last modified on	2022 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051930