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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043512
Receipt No. 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 2021/11/16

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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
Email 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
Email hhayashi@faculty.chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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
Email 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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

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
2021 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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