ClinicalTrials.Veeva

Menu

Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)

F

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Enrolling

Conditions

Hereditary Breast and Ovarian Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05409222
IIBSP-ECV-2019-103

Details and patient eligibility

About

  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.

Enrollment

45 estimated patients

Sex

Female

Ages

30 to 49 years old

Volunteers

No Healthy Volunteers

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.

Trial design

45 participants in 3 patient groups

Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy
Description:
Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy
Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy
Description:
Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy
Cohort 2: without preventive salpingo-oophorectomy
Description:
Healthy carriers who decide not to proceed to preventive surgery

Trial contacts and locations

1

Loading...

Central trial contact

Teresa Ramon y Cajal, MD PhD; Nuria Calvo, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems