RT Journal Article SR Electronic T1 Preventing Ovarian Cancer through early Excision of Tubes and late Ovarian Removal (PROTECTOR): protocol for a prospective non-randomised multi-center trial JF International Journal of Gynecologic Cancer JO Int J Gynecol Cancer FD BMJ Publishing Group Ltd SP ijgc-2020-001541 DO 10.1136/ijgc-2020-001541 A1 Gaba, Faiza A1 Robbani, Sadiyah A1 Singh, Naveena A1 McCluggage, W Glenn A1 Wilkinson, Nafisa A1 Ganesan, Raji A1 Bryson, Gareth A1 Rowlands, Gareth A1 Tyson, Charlotte A1 Arora, Rupali A1 Saridogan, Ertan A1 Hanson, Helen A1 Burnell, Matthew A1 Legood, Rosa A1 Evans, D Gareth A1 Menon, Usha A1 Manchanda, Ranjit A1 YR 2020 UL http://ijgc.bmj.com/content/early/2021/01/15/ijgc-2020-001541.abstract AB Background Risk-reducing salpingo-oophorectomy is the 'gold standard' for preventing tubo-ovarian cancer in women at increased risk. However, when performed in pre-menopausal women, it results in premature menopause and associated detrimental health consequences. This, together with acceptance of the central role of the fallopian tube in etiopathogenesis of high-grade serous carcinoma, by far the most common type of tubo-ovarian cancer, has led to risk-reducing early salpingectomy with delayed oophorectomy being proposed as a two-step surgical alternative for pre-menopausal women declining/delaying oophorectomy.Primary Objective To evaluate the impact on sexual function of risk-reducing early salpingectomy, within a two-step, risk-reducing, early salpingectomy with delayed oophorectomy tubo-ovarian cancer prevention strategy in pre-menopausal women at increased risk of tubo-ovarian cancer.Study Hypothesis Risk-reducing early salpingectomy is non-inferior for sexual and endocrine function compared with controls; risk-reducing early salpingectomy is superior for sexual/endocrine function, non-inferior for quality-of-life, and equivalent in satisfaction to the standard risk-reducing salpingo-oophorectomy.Trial Design Multi-center, observational cohort trial with three arms: risk-reducing early salpingectomy with delayed oophorectomy; risk-reducing salpingo-oophorectomy; controls (no surgery). Consenting individuals undergo an ultrasound, serum CA125, and follicle-stimulating hormone measurements and provide information on medical history, family history, quality-of-life, sexual function, cancer worry, psychological well-being, and satisfaction/regret. Follow-up by questionnaire takes place annually for 3 years. Women receiving risk-reducing early salpingectomy can undergo delayed oophorectomy at a later date of their choosing, or definitely by the menopause.Major Inclusion/Exclusion Criteria Inclusion criteria: pre-menopausal; aged >30 years; at increased risk of tubo-ovarian cancer (mutation carriers or on the basis of a strong family history); completed their family (for surgical arms). Exclusion criteria: post-menopausal; previous bilateral salpingectomy or bilateral oophorectomy; pregnancy; previous tubal/ovarian/peritoneal malignancy; <12 months after cancer treatment; clinical suspicion of tubal/ovarian cancer at baseline.Primary Endpoint Sexual function measured by validated questionnaires.Sample Size 1000 (333 per arm).Estimated Dates for Completing Accrual and Presenting Results It is estimated recruitment will be completed by 2023 and results published by 2027.Trial Registration Number ISRCTN registry: 25 173 360 (https://doi.org/10.1186/ISRCTN25173360).