UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043512 |
|---|---|
| Receipt number | R000049683 |
| Scientific Title | Clinical trial to examine the usefulness of diagnosis of lymph node metastases for gastric cancer using machine learning algorithm |
| Date of disclosure of the study information | 2021/03/10 |
| Last modified on | 2023/08/02 15:12:09 |
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Basic information
Public title
Clinical trial to examine the usefulness of diagnosis of lymph node metastases for gastric cancer using machine learning algorithm
Acronym
Clinical trial to examine the usefulness of diagnosis of lymph node metastases for gastric cancer using machine learning algorithm
Scientific Title
Clinical trial to examine the usefulness of diagnosis of lymph node metastases for gastric cancer using machine learning algorithm
Scientific Title:Acronym
Clinical trial to examine the usefulness of diagnosis of lymph node metastases for gastric cancer using machine learning algorithm
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the usefulness of a machine learnming algorithm established before in terms of potentials to (1)improve the diagnostic accuracy of pathologists (2)reduce the mental and physical burdens of the pathologists for the diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy (accuracy rate, sensitivity, and specificity) for the diagnosis of lymph node metastasis for gastric cancer
Key secondary outcomes
Duration, confidence, accuracy according to the histological types, and minimum size of lesion for the diagnosis of metastasis by pathologists
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) A case in which gastric cancer was diagnosed before surgery and gastrectomy or total gastrectomy with lymph node dissection was performed.
2) The histological type of the main lesion is papillary adenocarcinoma, well-differentiated tubular adenocarcinoma, moderately differentiated tubular adenocarcinoma, solid poorly differentiated adenocarcinoma, non-solid poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous cancer. What is
3) The section at the time of histopathological diagnosis is in a state that can withstand re-analysis.
Key exclusion criteria
1) Those containing special histological types such as adenosquamous carcinoma, squamous carcinoma, and carcinoid tumor in the main lesion
2) When the person in charge of research determines that participation in this research is inappropriate
3) When the research subject expresses refusal to participate in this research by opt-out
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Hayashi |
Organization
Chiba University Hospital (Medtech Link Center) / Frontier Medical Engineering Center
Division name
Esophageal-Gastro-Intestinal Surgery
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2109
hhayashi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hayashi |
Organization
Chiba University Hospital (Medtech Link Center) / Frontier Medical Engineering Center
Division name
Esophageal-Gastro-Intestinal Surgery
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2109
Homepage URL
hhayashi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Chiba University Graduate School of Medicine Ethics Review Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
| 2021 | Year | 03 | Month | 10 | 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
6
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
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
The subjects are patients who have undergone gastrectomy or total gastrectomy with lymph node dissection.
This study is an observational study using postoperative histopathological specimens and does not analyze medical information.
Management information
Registered date
| 2021 | Year | 03 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049683
| 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 |
