UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045702 |
|---|---|
| Receipt number | 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 | 2022/10/21 08:27:37 |
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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
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
k.mochizuki@med.showa-u.ac.jp
Sponsor or person
Institute
yushu University Beppu Hospital, Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051930
