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Evaluation of genetic counseling for disclosure of research-identified genetic mutations in breast cancer patients: a multicenter prospective observational cohort study

Evaluation of genetic counseling for disclosure of research-identified genetic mutations in breast cancer patients: a multicenter prospective observational cohort study - Evaluation of genetic counseling for disclosure of research-identified genetic mutations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000038229
Enrollment
150
Registered
2019-10-08
Start date
2017-12-20
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

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following 1. Diagnosis as a carrier of a clinically actionable germline pathogenic/likely pathogenic genetic mutation (BRCA1, BRCA2, ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, STK11, TP53, BRIP1, MSH2, MLH1, MSH6, PMS2, EPCAM, RAD51C, RAD51D, RYR2, RB1)in the previous study(Kyoto University Ethical Committe G424) 2. Regular follow-up in the participating hospitals 3. Consent to disclosure of the research results, genetic counseling and this study

Exclusion criteria

Exclusion criteria: Patients who meet one of the following 1. Lost to follow-up 2. Declining disclosure of the research results, genetic counseling, or participation in this study 3. Previous genetic counseling and diagnosis as a carrier on clinical genetic testing

Design outcomes

Primary

MeasureTime frame
The change in GCOS-24 score between before and after genetic counseling (GCOS-24:The Genetic Counseling Outcome Scale)

Secondary

MeasureTime frame
Associations between the changes in GCOS-24 scores and patient factors

Countries

Japan

Contacts

Public ContactNobuko Kawaguchi-Sakita

Kyoto University Hospital Clinical Oncology

nobuko75@kuhp.kyoto-u.ac.jp075-751-3660

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026