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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000045702
Receipt No. R000051930
Scientific Title Molecular and clinicopathological features of depressed T2 colorectal cancer
Date of disclosure of the study information 2021/10/08
Last modified on 2021/10/08

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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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
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
2021 Year 10 Month 08 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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