NCT05409222

Brief Summary

  1. 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. 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. 3.Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3.6 years

First QC Date

March 13, 2021

Last Update Submit

June 3, 2022

Conditions

Hereditary Breast and Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy

    Questionnaire to measure quality of life in post-menopausal women (the Mencav questionnaire). This questionnaire consists of questions with 5 possible answers, answer 1 is the worst result and question 5 is the best result, so low scores mean worse results and high scores better results.

    5 years

Secondary Outcomes (8)

  • To compare the impact of hormone replacement therapy on number and description of cardiovascular events

    5 years

  • To compare the impact of hormone replacement therapy on number and description of cardiovascular events

    5 years

  • To compare the impact of hormone replacement therapy on number and description of cardiovascular events

    5 years

  • To compare the impact of hormone replacement therapy on number and description of cardiovascular events

    5 years

  • 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

    5 years

  • +3 more secondary outcomes

Study Arms (3)

Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy

Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy

Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy

Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy

Cohort 2: without preventive salpingo-oophorectomy

Healthy carriers who decide not to proceed to preventive surgery

Eligibility Criteria

Age30 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women identified and followed at the Hospital de la Santa Creu i Sant Pau.

You may qualify if:

  • Age between 30 and 49 years
  • 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.

You may not qualify if:

  • Personal history of oophorectomy for benign or malignant ovarian pathology.
  • Personal history of breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplastic Syndromes, HereditaryOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Teresa Ramon y Cajal, MD PhD

    Hospital Santa Cruz y San Pablo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Ramon y Cajal, MD PhD

CONTACT

+ 34 93 556 56 38tramon@santpau.cat

Nuria Calvo, MD

CONTACT

+ 34 93 556 56 38ncalvo@santpau.cat

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2021

First Posted

June 8, 2022

Study Start

March 12, 2020

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

ES(1)