menu

Protector

Information for health professionals menu

Study design

Design: Multi-centre, observational cohort controlled study with three arms: risk reducing early salpingectomy with delayed oophorectomy (RRESDO); risk reducing salpingo-oophorectomy (RRSO); controls (no surgery).

Inclusion criteria: Premenopausal women; >30 years; at increased risk of ovarian cancer (mutation carriers or on the basis of a strong family history; completed their family (for surgical arms).

Exclusion criteria: Postmenopausal women; previous bilateral salpingectomy or bilateral oophorectomy; pregnancy; previous tubal/ovarian/peritoneal malignancy; <12 months post cancer treatment; clinical suspicion of tubal/ovarian cancer at baseline.

Recruitment: Through NHS cancer genetics/high-risk familial cancer clinics/general gynaecology clinics/gynaecological oncology clinics/GP surgeries/clinical referrals/supporting charities/self-referral.

Primary outcome: Sexual function.

Secondary outcomes: Endocrine function/menopause; regret/satisfaction; surgical morbidity; quality of life/psychological health; number of intraepithelial carcinomas/invasive cancers; utility scores for early-salpingectomy; cost-effectiveness.

Recruitment: Participants will be identified through NHS cancer genetics/ high-risk familial cancer clinics, general gynaecology clinics, gynaecological oncology clinics, GP-surgeries, clinical referrals, supporting charities or by self-referral.  Interested participants will receive thorough counselling and Participation Information Sheets for informed decision making.

Interventions: Participants can choose any one of the three study arms (a) RRES and DO; (b) RRSO; or (c) Controls (no surgery). Consenting individuals for the surgical arms will undergo a hormonal profile (FSH), ultrasound, CA125 and complete questionnaires collecting information on medical history, family history, quality of life, sexual function, cancer worry, psychological well-being and satisfaction/regret. All women undergoing surgery will have cytological and histological assessment using a SEE-FIMM protocol and will undergo central pathology review. Post-surgery FSH levels will be tested and follow up questionnaires sent at 3 months and annually. Controls will not undergo surgery, and will have their FSH levels checked and complete questionnaires at baseline and annually for three years. A small number of women will be invited to attend face to face/telephone semi-structured in depth interviews to determine attitudes towards RRESDO (qualitative sub-study). This will help address the paucity of qualitative data on acceptability.

For further details please see our study factsheet or view details of the study on the ISRCTN registry.

Return to top