Clinical trial NCT05409222: Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)
Official title: Study of Quality of Life Post Preventive Salpingo-oophorectomy in Healthy BRCA1/2 and PALB2 Mutation Carriers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hereditary Breast and Ovarian Cancer
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women identified and followed at the Hospital de la Santa Creu i Sant Pau.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: To compare the impact of hormone replacement therapy on number and description of cardiovascular events
timeFrame: 5 years
measure: To compare the impact of hormone replacement therapy on number and description of cardiovascular events
timeFrame: 5 years
measure: To compare the impact of hormone replacement therapy on number and description of cardiovascular events
timeFrame: 5 years
measure: To compare the impact of hormone replacement therapy on number and description of cardiovascular events
timeFrame: 5 years
measure: To compare the impact of hormone replacement therapy on number and description of bone loss related events in premenopausal carriers after salpingo-oophorectomy we will perform bone densitometry
timeFrame: 5 years
measure: Comparison of overall cancer survival between women deciding risk-reducing surgery and those rejecting it.
timeFrame: 5 years
measure: Comparison of mean of breast cancer specific survival between women deciding gynecological surgery and those rejecting surgery.
timeFrame: 5 years
measure: Comparison of gynecologic cancer survival between women deciding preventive surgery and those rejecting it.
timeFrame: 5 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Hospital Santa Cruz y San Pablo
name: Teresa Ramon y Cajal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: