UMIN ID: UMIN000056645
Registered date:06/01/2025
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
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Breast cancer |
| Date of first enrollment | 2025/01/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The increase rate in the number of genetic counseling sessions conducted before and after the implementation of AI-based preliminary screening system for HBOC. |
|---|---|
| Secondary Outcome | -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. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Department of Genetic Medicine, Kanagawa Cancer Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | -Japan Society for the Promotion of Science (JSPS) Grant-in-Aid for Scientific Research (B) -Kanagawa Cancer Center Clinical Research Institute Independent Research Fund |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ann Sato |
| Address | 2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, Japan Japan 241-8515 |
| Telephone | 045-520-2222 |
| satou.18012@kanagawa-pho.jp | |
| Affiliation | 1)Kanagawa Cancer Center 2)Kanagawa University of Human Services 1)Department of Genetic Medicine 2)Graduate School of Health Innovation |
| scientific contact | |
| Name | Hiroto Narimatsu |
| 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 Japan |
| Telephone | 045-520-2222 |
| hiroto-narimatsu@umin.org | |
| Affiliation | 1)Kanagawa Cancer Center 2)Kanagawa Cancer Center Research Institute 3)Kanagawa University of Human Services 1)Department of Genetic Medicine 2)Cancer Prevention and Cancer Control Division 3)Graduate School of Health Innovation |