UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038257 |
|---|---|
| Receipt number | R000043266 |
| Scientific Title | Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2021/04/12 18:54:03 |
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Basic information
Public title
Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Acronym
Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Scientific Title
Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Scientific Title:Acronym
Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Region
| Japan |
Condition
Condition
T2 colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop lymph node metastasis prediction software using artificial intelligence in order to identify cases that do not require lymph node dissection in T2 colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ability to predict lymph node metastasis in T2 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
Cases of surgically resected T2 colorectal cancer that can be histologically diagnosed presense of lymph node metastasis.
Key exclusion criteria
Preoperative treatment.
Patients who have not undergone lymph node dissection with local treatment alone.
Double cancer.
Multiple cancer.
Hereditary colorectal cancer.
Colitic cancer.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Nakahara |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki Ward, Yokohama City, Kanagawa Prefecture
TEL
0459497000
ke_nakahara@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Nakahara |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
224-8503
Address
35 1Chigasaki Chuo,Tsuzuki Ward,Yokohama City,Kanagawa Prefecture
TEL
0459497000
Homepage URL
ke_nakahara@yahoo.co.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 1Chigasaki Chuo,Tsuzuki Ward,Yokohama City,Kanagawa Prefecture
Tel
0459497000
ke_nakahara@yahoo.co.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
| 2019 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 10 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043266
