UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038609 |
|---|---|
| Receipt number | R000043857 |
| Scientific Title | Prediction of lymph node metastasis in T1 colorectal cancer with artificial intelligence |
| Date of disclosure of the study information | 2019/11/22 |
| Last modified on | 2020/11/18 09:14:04 |
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Basic information
Public title
Prediction of lymph node metastasis in T1 colorectal cancer with artificial intelligence
Acronym
AMED T1 study
Scientific Title
Prediction of lymph node metastasis in T1 colorectal cancer with artificial intelligence
Scientific Title:Acronym
AMED T1 study
Region
| Japan |
Condition
Condition
T1 colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop the predicting model for lymph node metastasis of T1 colorectal cancer
Basic objectives2
Others
Basic objectives -Others
Strategy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive value (sensitivity, specificity, accuracy, AUC)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with T1 colorectal cancer who received complete treatment for submucosal invasive colorectal cancer with endoscopic resection or surgical resection
2.Written informed consent
Key exclusion criteria
1.Lynch syndrome
2.Familial adenomatous polyposis
3.Ulcerative colitis
4.Neo adjuvant chemo- or radio-therapy
5.Synchronous invasive carcinoma
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | SHIN-EI |
| Middle name | |
| Last name | KUDO |
Organization
Showa University Nothern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL
045-949-7000
kudos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuro |
| Middle name | |
| Last name | Ichimasa |
Organization
Showa University Nothern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL
045-949-7000
Homepage URL
ichitommy14@yahoo.co.jp
Sponsor or person
Institute
Showa University Nothern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Nothern Yokohama Hospital
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
Tel
045-949-7000
irb02syh@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
| 2019 | Year | 11 | Month | 22 | 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
4169
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
| 2017 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study
Management information
Registered date
| 2019 | Year | 11 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043857
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
