Clinical trial · Interventional
Breast Cancer Risk After Diagnostic Gene Sequencing
Clinical Application of the European Horizon 2020 Research Project "BRIDGES" - Study of the Psychological Impact of Breast Cancer Risk Communication in Cancer Genetics Based on the Personalized Estimation of the BOADICEA V5/PLUS Model
NCT04145817CI-TRIAL-00097759BRIDGEScohort2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genetic Predisposition to Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast cancer risk polygenic risk score (PRS) | Genetic | — | UNRESOLVED |
| BRIDGES gene panel testing | Genetic | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- genetic counselling
- description
- Genetic counselling (PRS for risk estimation) and questionnaires in the participating Cancer Genetic Clinics for healthy woman relative of a person first tested in the family (index case) who received a positive genetic test result or a negative non-informative test result
- interventionNames
- Genetic: BRIDGES gene panel testing
- Genetic: Breast cancer risk polygenic risk score (PRS)
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Psychosocial Assessment in Hereditary Cancer questionnaire (PAHC).
- timeFrame
- Up to 6 months
- description
- Breast or ovarian cancer risk perception (the impact of communicating a personalized breast cancer risk using the BOADICEAV5/PLUS model) using a PAHC questionnaire. Questionnaire items are responded on a 4-level scale from 1 (Not at all) to 4 (Very much). Item response scores are averaged and standardized on a 0 to 100 scale, with an increased value indication more severe difficulties.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthy woman, relative of a family member first tested (index case) who received a positive genetic test result (presence of a BRCA1 or BRCA2 deleterious variant or a moderate-penetrance BC gene deleterious variant) ; a. at Cologne University Hospital (Germany), these healthy women may also be relatives of women (index case) who received a negative non-informative test result; 2. Who accept BRIDGES gene panel testing and the breast cancer risk PRS; 3. Aged 18 years or over with no upper limit; 4. Able to give informed written consent in accordance with national/local regulations and procedures; 5. Able to understand the questionnaire language of the participating genetic clinic. Exclusion Criteria: 1. Woman affected with BC, with recurrent BC, with metastatic BC, with an ovarian cancer (OC) or cancer of any other site; 2. Aged under 18 years old; 3. Unable to give informed written consent; 4. Unable to understand the questionnaire language of the participating clinic; 5. Unable to answer the questionnaire due to physical or cognitive disturbance
References
Publications (3)
- RESULTBredart A, De Pauw A, Tuchler A, Lakeman IMM, Anota A, Rhiem K, Schmutzler R, van Asperen CJ, Devilee P, Stoppa-Lyonnet D, Kop JL, Dolbeault S. Genetic clinicians' confidence in BOADICEA comprehensive breast cancer risk estimates and counselees' psychosocial outcomes: A prospective study. Clin Genet. 2022 Jul;102(1):30-39. doi: 10.1111/cge.14147. Epub 2022 May 16. PMID 35508697
- RESULTBredart A, Kop JL, Tuchler A, De Pauw A, Cano A, Dick J, Rhiem K, Devilee P, Schmutzler R, Stoppa-Lyonnet D, Dolbeault S. Assessment of psychosocial difficulties by genetic clinicians and distress in women at high risk of breast cancer: a prospective study. Eur J Hum Genet. 2022 Sep;30(9):1067-1075. doi: 10.1038/s41431-022-01096-9. Epub 2022 Apr 11. PMID 35399119
- RESULTBredart A, De Pauw A, Anota A, Tuchler A, Dick J, Muller A, Kop JL, Rhiem K, Schmutzler R, Devilee P, Stoppa-Lyonnet D, Dolbeault S. Information needs on breast cancer genetic and non-genetic risk factors in relatives of women with a BRCA1/2 or PALB2 pathogenic variant. Breast. 2021 Dec;60:38-44. doi: 10.1016/j.breast.2021.08.011. Epub 2021 Aug 23. PMID 34455229