UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050534 |
|---|---|
| Receipt number | R000057550 |
| Scientific Title | Risk stratification of lymph node metastasis in T2 colorectal cancer |
| Date of disclosure of the study information | 2023/03/09 |
| Last modified on | 2025/03/13 10:28:35 |
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Basic information
Public title
Risk stratification of lymph node metastasis in T2 colorectal cancer
Acronym
Metastasis risk to lymph node in T2 colorectal cancer
Scientific Title
Risk stratification of lymph node metastasis in T2 colorectal cancer
Scientific Title:Acronym
Risk stratification of lymph node metastasis in T2 colorectal cancer
Region
| Japan | Asia(except Japan) | Europe |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To stratify the risk for lymph node metastasis in T2 colorectal cancer
Basic objectives2
Others
Basic objectives -Others
Predicting power
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and AUC for the presence of 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
| 18 | years-old | <= |
Age-upper limit
| 130 | years-old | > |
Gender
Male and Female
Key inclusion criteria
T2 colorectal cancer resected surgically
Key exclusion criteria
Patients with (1) familial adenomatous polyposis, (2) Lynch syndrome, (3) inflammatory bowel disease, (4) invasion to deeper than muscularis propria in surgical specimens, (5) preoperative chemotherapy or radiotherapy (6) lesions without lymph node dissection.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Katsuro |
| Middle name | |
| Last name | Ichimasa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama city
TEL
+81459497535
ichimasa@nus.edu.sg
Public contact
Name of contact person
| 1st name | Katsuro |
| Middle name | |
| Last name | Ichimasa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama city
TEL
+81459497535
Homepage URL
ichimasa@nus.edu.sg
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama city
Tel
+81459497535
m-rinri@ofc.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
| 2023 | Year | 03 | Month | 09 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To develop the artificial intelligence system predicting the presence or absence of lymph node metastasis in T2 colorectal cancer using patient clinico-pathological factors
Management information
Registered date
| 2023 | Year | 03 | Month | 08 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057550
