Clinical trial · Observational
Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)
Study of Quality of Life Post Preventive Salpingo-oophorectomy in Healthy BRCA1/2 and PALB2 Mutation Carriers
- 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)
1. Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline HRT. 2. Premenopausal mutation carriers treated with PBSO who choose HRT have a comparable overall survival and specific survival for breast / gynecological cancer to women who undergo surgery and refuse to receive HRT. 3. Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.
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 |
|---|---|---|---|
| Hereditary Breast and Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy
- description
- Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy
- label
- Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy
- description
- Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy
- label
- Cohort 2: without preventive salpingo-oophorectomy
- description
- Healthy carriers who decide not to proceed to preventive surgery
Primary outcomes (1)
- measure
- To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 30 and 49 years 2. Being a member of a family with a history of hereditary breast and ovarian cancer, with a cancer risk\> 10% or being a carrier of the BRCA1 / 2 or PALB2 mutation. Exclusion Criteria: 1. Personal history of oophorectomy for benign or malignant ovarian pathology. 2. Personal history of breast cancer.
References
Publications (0)
Data not yet available