UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056905 |
|---|---|
| Receipt number | R000064715 |
| Scientific Title | Evaluation of Moderately Differentiated Adenocarcinoma as a Risk Factor for Lymph Node Metastasis in Colorectal T1 Cancer |
| Date of disclosure of the study information | 2025/02/05 |
| Last modified on | 2025/02/02 15:07:04 |
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Basic information
Public title
Evaluation of Moderately Differentiated Adenocarcinoma as a Risk Factor for Lymph Node Metastasis in Colorectal T1 Cancer
Acronym
Evaluation of Moderately Differentiated Adenocarcinoma as a Risk Factor for Lymph Node Metastasis in Colorectal T1 Cancer
Scientific Title
Evaluation of Moderately Differentiated Adenocarcinoma as a Risk Factor for Lymph Node Metastasis in Colorectal T1 Cancer
Scientific Title:Acronym
Evaluation of Moderately Differentiated Adenocarcinoma as a Risk Factor for Lymph Node Metastasis in Colorectal T1 Cancer
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the existing pathological data of T1 colorectal cancer patients who underwent resection with lymph node dissection at our institution and to investigate whether moderately differentiated adenocarcinoma (tub2) is a risk factor for lymph node metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Rate of Lymph Node Metastasis in T1 Colorectal Cancer.
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 CRCs resected between 2001 and 2023 in our hospital.
Key exclusion criteria
FAP,Lynch syndrome,Inflammatory bowel disease,Synchronous distant metastasis or advanced CRCs,TEM,Endoscopic resection alone, is excluded.
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Semba |
Organization
Showa University
Division name
Showa University Northern Yokohama Hospital, Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
0459497000
semba@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Semba |
Organization
Showa University
Division name
Showa University Northern Yokohama Hospital, Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
0459497000
Homepage URL
semba@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University Northern Yokohama Hospital, Digestive Disease Center
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
Tel
0459497000
semba@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 05 | 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
1057
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
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between lymph node metastasis and pathological findings was evaluated using existing pathological specimens.
Management information
Registered date
| 2025 | Year | 02 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064715
