UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056645 |
|---|---|
| Receipt number | R000064744 |
| Scientific Title | Evaluation of the effectiveness of an AI-Based preliminary screening system for hereditary breast and ovarian cancer (multicenter collaborative study) |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/01/06 22:52:02 |
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Basic information
Public title
A study to evaluate the effectiveness of an AI-based system for identifying hereditary breast and ovarian cancer risk, conducted in collaboration with multiple medical institutions
Acronym
A study to evaluate the effectiveness of an AI-based system for identifying hereditary breast and ovarian cancer risk, conducted in collaboration with multiple medical institutions
Scientific Title
Evaluation of the effectiveness of an AI-Based preliminary screening system for hereditary breast and ovarian cancer (multicenter collaborative study)
Scientific Title:Acronym
Evaluation of the effectiveness of an AI-Based preliminary screening system for hereditary breast and ovarian cancer (multicenter collaborative study)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the AI-based preliminary screening system for Hereditary Breast and Ovarian Cancer (HBOC) that we have developed will be evaluated by personnel previously responsible for the screening process across multiple institutions in Japan, including those with Certified Genetic Counselors (CGCs) and those without.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The increase rate in the number of genetic counseling sessions conducted before and after the implementation of AI-based preliminary screening system for HBOC.
Key secondary outcomes
-The increase rate in the number of genetic tests, including BRCA1/2, conducted before and after the implementation of this system.
-The number of preliminary screenings performed before the implementation of this system.
-The number of preliminary screenings conducted using this system after its implementation.
-The time required for preliminary screenings using this system after its implementation.
-The number of high-risk cases identified through this system after its implementation.
-Quantitative and qualitative data on the usability of this system from research participants after its implementation.
-Quantitative and qualitative data on potential improvements to this system from physicians involved in breast cancer care.
-Comparison with the data from "Evaluation of the Utility of the AI-driven Preliminary Screening System for Hereditary Breast and Ovarian Cancer after Implementation" (2024-EPI-22), including the increase rate in the number of referrals to genetic counseling outpatient services and the increase rate in the number of genetic tests, including BRCA1/2, before and after the implementation of the system.
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
Individuals who meet one of the following criteria:
-Patients newly diagnosed with breast cancer at each participating research facility (Cohort A).
-First-visit patients at each participating research facility who were diagnosed with or suspected of having breast cancer (Cohort B).
Key exclusion criteria
Individuals who meet one of the following criteria:
-Patients whose physical or mental condition, as determined by the attending physician, is deemed unsuitable for enrollment in this study.
-Patients with a history of undergoing genetic counseling or genetic testing related to HBOC.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
1)Kanagawa Cancer Center
2)Kanagawa Cancer Center Research Institute
3)Kanagawa University of Human Services
Division name
1)Department of Genetic Medicine 2)Cancer Prevention and Cancer Control Division 3)Graduate School of Health Innovation
Zip code
241-8515
Address
1)2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, Japan 2)2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, Japan 3)3-25-10 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
045-520-2222
hiroto-narimatsu@umin.org
Public contact
Name of contact person
| 1st name | Ann |
| Middle name | |
| Last name | Sato |
Organization
1)Kanagawa Cancer Center 2)Kanagawa University of Human Services
Division name
1)Department of Genetic Medicine 2)Graduate School of Health Innovation
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-520-2222
Homepage URL
satou.18012@kanagawa-pho.jp
Sponsor or person
Institute
Department of Genetic Medicine, Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
-Japan Society for the Promotion of Science (JSPS) Grant-in-Aid for Scientific Research (B)
-Kanagawa Cancer Center Clinical Research Institute Independent Research Fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, Japan
Tel
045-520-2222
clinical_trials@kcch.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
ときわ会常磐病院（福島県）、済生会横浜市南部病院（神奈川県）、昭和大学横浜市北部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 06 | 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
| 2024 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064744
