Prevention of ovarian cancer Cancer Ovarian cancer
Conditions
Interventions
Current interventions as of 14/10/2025:
Participants who meet the eligibility criteria and who have been identified through various NHS outpatient clinics, GP-surgeries or who have self-referred to
controls (no surgery).
Baseline investigations
Participants enrolled into the two surgical arms (RRESDO/RRSO) have a CA125 and transvaginal ultrasound of the pelvis. Participants in all three arms ha
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/10/2025: 1. Women at increased risk of ovarian cancer: BRCA1/BRCA2 mutation carriers; BRIP1/PALB2/RAD51C/RAD51D mutation carriers; strong family history of breast and ovarian cancer or ovarian cancer alone. 2. Premenopausal 3. Aged =30 years. 4. Completed family (for surgical arms) _____ Previous inclusion criteria as of 14/10/2025: 1. Women at increased risk of ovarian cancer: BRCA1/BRCA2 mutation carriers; RAD51C/RAD51D/BRIP1 mutation carriers; strong family history of breast and ovarian cancer or ovarian cancer alone. 2. Premenopausal 3. Aged =30 years. 4. Completed family (for surgical arms)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/10/2025: 1. Previous bilateral-salpingectomy or bilateral-oophorectomy. 2. Postmenopausal (amenorrhoea =1year (uterus in situ) / FSH >40). 3. Previous tubal/ovarian/peritoneal malignancy 4. 40). 3. Previous tubal/ovarian/peritoneal malignancy 4. <12 months post cancer treatment 5. Pregnancy 6. Clinical suspicion of tubal/ovarian cancer at baseline 7. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 14/10/2025: 1. Sexual function measured using the Sexual Activity Questionnaire and Sexual Quality of Life 3D (SQOL-3D) questionnaire completed at baseline, 3 months post surgery and annually. 2. Incidence of ovarian cancer after (not at) RRES, and before or at delayed oophorectomy (DO), in women with normal histology at surgery. _____ Previous primary outcome measure: Sexual function measured using the Sexual Activity Questionnaire and Sexual Quality of Life 3D (SQOL-3D) questionnaire completed at baseline, 3 months post surgery and annually. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/10/2025: 1. Endocrine function and menopause is measured using the FACT-ES questionnaire completed at baseline, 3 months post surgery, annually and FSH levels measured 3 months after surgery and annually (early salpingectomy/control arm) 2. Quality of life measured using the EQ5D-5L questionnaire completed at baseline, 3 months post surgery and annually 3. Satisfaction/regret is measured using the 5-item Decision Regret Scale (O'Connor, Ottawa 1996) and 1-item ('I am satisfied with the decision I have made' on a 5-point Likert scale from Madalinska et al, 2005) completed at baseline, 3 months post surgery and annually 4. Surgical morbidity measured by recording complications experienced by the participant 4 weeks after surgery during the post-surgical clinic review 5. Psychological health measured using the Hospital Anxiety and Depression Scale (HADS), assessing cancer worry using the 4-item scale from Lerman et al and measuring intrusive thoughts using the Impact of Events Scale (7 intrusive items, Horowitz et al, 1997) completed at baseline, 3 months post surgery and annually 6. Number of serous-tubal-intraepithelial-carcinoma (STIC)/invasive (tubal/ovarian/peritoneal/non-ovarian) cancers will be recorded following histopathology review by a central pathology review committee using the SEE-FIM protocol 7. Utility scores for early salpingectomy will be derived using the Sexual Quality of Life 3D (SQOL-3D) questionnaire 8. Cost-effectiveness (incremental cost effectiveness ratio per quality adjusted life years (ICER/QALY)) of early salpingectomy/delayed oophorectomy will be established via a cost utility analysis performed using a Markov model 9. A national register of women undergoing early salpingectomy will be created by collating the details of all participants who have undergone early salpingectomy as part of the trial _____ Previous secondary outcome measures: 1. Endocrine function and menopause is measured usin | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public Contact. PROTECTOR Study Team
Outcome results
None listed