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Breast Cancer Risk After Diagnostic Gene Sequencing

NCT04145817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2025-11-24

No results posted yet for this study

Summary

Study of the psychological impact of breast cancer risk communication in Cancer Genetics based on the personalized estimation of the BOADICEA V5/PLUS model ("Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-version 5 or PLUS").

Conditions

  • Genetic Predisposition to Disease

Interventions

GENETIC

BRIDGES gene panel testing

The "Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-BOADICEAV5/PLUS" predicts lifetime and age-specific breast cancer (BC) risks on the basis of family history, all known BC genes test-results, common single nucleotide polymorphisms (SNPs) combined in a PRS, and other non-genetic risk factors. This model is developed within the BRIDGES consortium.

GENETIC

Breast cancer risk polygenic risk score (PRS)

The "Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-BOADICEAV5/PLUS" predicts lifetime and age-specific breast cancer (BC) risks on the basis of family history, all known BC genes test-results, common single nucleotide polymorphisms (SNPs) combined in a PRS, and other non-genetic risk factors. This model is developed within the BRIDGES consortium.

BEHAVIORAL

Questionnaires

Self-administered questionnaires for counselees to evaluate Psychosocial Aspects of Hereditary Cancer (PAHC), Breast Cancer risk perception adequacy, risk communication within the family and cancer risk management choice,

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Pierre FUMOLEAU, MD · Institut Curie

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2021-08-27
Completion
2022-03-03

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145817 on ClinicalTrials.gov