Preventing Ovarian Cancer through early Excision of Tubes and late Ovarian Removal

Study ID: 39196
Short Title: PROTECTOR
Trust Name: PHU,UHS
Recruitment Site: Queen Alexandra Hospital,Southampton General Hospital
Disease Area: Gynaecological cancers
Phase: N/A
Expected End Date: 30/09/2024
Postcode: PO6 3LY
SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

1. Women at high-risk of ovarian cancer (BRCA1/BRCA2 mutation carriers, or deemed to be at increased risk from a strong family history of breast and/or ovarian cancer or RAD51C/ RAD51D/ BRIP1 mutation carriers. 2. Premenopausal ≥30years. 3. Completed family (for early surgical arms only).

1. Previous bilateral-salpingectomy or bilateral-oophorectomy. 2. Postmenopausal (amenorrhoea ≥1year (uterus insitu) / FSH > 40). 3. Previous tubal/ ovarian/ peritoneal malignancy. 4. < 12 months post cancer treatment. 5. Pregnancy** 6. Clinical suspicion of tubal/OC at baseline. 7. Inability to provide informed consent.

Ovarian cancer is the leading cause of deaths from gynaecological cancers. Despite massive funding in drugs and new treatment strategies, survival rates remain poor. Only 3 in 10 women are alive at 10years. Women with a > 10% risk of getting ovarian cancer are considered high-risk. 10% ovarian cancers are familial. The commonest cause is a fault/alteration in BRCA1/BRCA2 genes. BRCA1/BRCA2 carriers have a 17-44% risk of developing ovarian cancer and 69-72% risk of developing breast cancer. There is currently no NHS screening programme for ovarian cancer. Best current practice is to offer women at increased-risk, an operation to remove their fallopian tubes and ovaries on completing their family. This significantly reduces the risk of ovarian cancer by 90% but leads to early menopause. Early menopause has serious implications including, hot flushes, sweats, mood changes and pain during intercourse. Additionally, it increases the risk of thinning of the bones, heart disease, stroke and dementia. Many women avoid/delay prevention due to this. However, a significant number of ovarian cancers actually start in the fallopian-tube. This has led to an attractive alternative ‘two-stage’ proposal to prevent ovarian cancer. The first-stage involves removing the fallopian-tubes (earlysalpingectomy) alone. This is followed by a second-operation (delayed oophorectomy) to remove the ovaries after they have gone through the menopause. This offers protection against ovarian cancer in younger women whilst avoiding the negative health consequences of early menopause. However, long term consequences of this new approach have not been adequately studied. Our UK-wide study compares old and new strategies for ovarian cancer prevention. The study evaluates the impact on sexual function, endocrine function, quality-of-life and cost-effectiveness of this new strategy in high-risk women by comparing it to the traditional strategy of removing both tubes and ovaries as well as outcomes in women who don’t have an operation (controls). Women entering the study can choose whichever strategy they prefer.

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