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

Evaluation of the effectiveness of an AI-Based preliminary screening system for hereditary breast and ovarian cancer (multicenter collaborative study) - Evaluation of the effectiveness of an AI-Based preliminary screening system for hereditary breast and ovarian cancer (multicenter collaborative study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056645

Enrollment

200

Registered

2025-01-06

Start date

2025-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
-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.	—

Measure

Time frame

-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.

—

Countries

Japan

Contacts

Public ContactAnn Sato

1)Kanagawa Cancer Center 2)Kanagawa University of Human Services 1)Department of Genetic Medicine 2)Graduate School of Health Innovation

satou.18012@kanagawa-pho.jp045-520-2222

Outcome results