Skip to content

Decision-making regarding the Intensified Early Detection and Follow-up Program (IFNP) versus risk-reducing mastectomy in BRCA1/2 mutation carriers at the FBREK Center, University Hospital Düsseldorf, during 2004–2023

Decision-making regarding the Intensified Early Detection and Follow-up Program (IFNP) versus risk-reducing mastectomy in BRCA1/2 mutation carriers at the FBREK Center, University Hospital Düsseldorf, during 2004–2023

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037270
Enrollment
300
Registered
2025-09-09
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

C50

Interventions

Group 1: Participants with an increased risk of breast and ovarian cancer who have presented at the Center for Familial Breast and Ovarian Cancer at the University Hospital Düsseldorf over the past 20

Sponsors

Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. BRCA1/2 mutation carriers at the FBREK Center Düsseldorf from 2004–2023, regardless of disease status. 2. Consent for re-contact for clinical studies has been given. 3. Consent to participate in the prospective questionnaire study.

Exclusion criteria

Exclusion criteria: Patients with high-risk mutations who do not meet the inclusion criteria listed above and/or who presented at the FBREK Center Düsseldorf outside the period 2004–2023.

Design outcomes

Primary

MeasureTime frame
Determination of the rate of risk-reducing mastectomies in the cohort of BRCA1/2 mutation carriers at the FBREK Center of the University Women’s Hospital Düsseldorf, in relation to factors that may influence their decision-making regarding participation in the intensified early detection program versus opting for risk-reducing mastectomy.

Secondary

MeasureTime frame
Secondary outcome is the evaluation of the subjective satisfaction of BRCA1/2 mutation carriers with the counseling they have received regarding intensified early detection versus risk-reducing mastectomy. These data will be prospectively collected by means of the questionnaire.

Countries

Germany

Contacts

Public ContactNadia Stamm

Klinik für Frauenheilkunde und Geburtshilfe

studienzentrale.frauenklinik@med.uni-duesseldorf.de+492118117506

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026