UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048642 |
|---|---|
| Receipt number | R000055393 |
| Scientific Title | Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/08/10 12:41:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Acronym
Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Scientific Title
Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Scientific Title:Acronym
Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Extraction of Risk Factors for Lymph Node Metastasis in Colorectal T2 Cancer. Construction of Artificial Intelligence to Predict Lymph Node Metastasis from Pathological Images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and area under the curve) for 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Surgical resected colon tumor
Key exclusion criteria
Cases with difficult pathological evaluation
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kouyama |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL
045-949-7000
kouyuta1101@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kouyama |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL
045-949-7000
Homepage URL
kouyuta1101@yahoo.co.jp
Sponsor or person
Institute
Digestive Disease Center, 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
Address
1-5-8, hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8000
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
| 2022 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 30 | 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 | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Accumulating pathological preparation images, and constructing AI.
Management information
Registered date
| 2022 | Year | 08 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055393
