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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Faiza Gaba
+44 (0)20 7882 8491
f.gaba@qmul.ac.uk


Dr Ranjit Manchanda
+44 (0)7979 884575
r.manchanda@qmul.ac.uk


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Be Part of Research - Trial Details - Early removal of Fallopian tubes and delayed removal of ovaries in women at high risk of ovarian cancer
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Early removal of Fallopian tubes and delayed removal of ovaries in women at high risk of ovarian cancer

Recruiting

Open to: Female

Age: Adult

Canterbury Leicester London London Belfast Cambridge Manchester Birmingham London London London Aberdeen Tunbridge Wells Norwich Gateshead Bristol Brighton Birmingham Oxford Chertsey Cardiff London Portsmouth London Dundee Romford Southampton

Medical Conditions

Prevention of ovarian cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.



Background and study aims
Some women have an inheritable fault in their genetic code which increases their risk of developing ovarian cancer. Genes in which a fault may lie are BRCA1/ BRCA2/ RAD51C/ RAD51D/ BRIP1. Some women with a strong family history of ovarian cancer or breast and ovarian cancer may also be at increased risk. There is currently no screening programme for ovarian cancer available on the NHS. Therefore current practice is to offer women at increased risk, once they have completed their family, an operation to remove their fallopian tubes and ovaries. This procedure is called risk-reducing salpingo-oophorectomy. This is the best known way to prevent ovarian cancer in women at increased risk. However, in women who are premenopausal it leads to early menopause. Early menopause has serious health implications. It results in menopausal type symptoms (e.g. hot flushes, changes in mood, reduced sex drive), increased risk of osteoporosis (brittle bones), heart disease, stroke, dementia and sexual problems. Research suggests many ovarian cancers start in the fallopian tube. This has led to the proposal of an alternative strategy to prevent ovarian cancer. This involves having the operation in two stages. The first operation involves removing the fallopian tubes alone. This is called 'early salpingectomy’. The second operation removes the ovaries after natural menopause (average age 51 in the UK). This is called 'delayed oophorectomy’. The advantage of this two-stage alternative is that it offers some protection against ovarian cancer in young women whilst avoiding negative health consequences of early menopause.
The aim of the PROTECTOR study is to assess the impact of this two-stage alternative approach on sexual function. The study also evaluates the impact on quality of life, hormonal well-being, psychological well-being and overall satisfaction. Outcomes from this new approach are compared to the traditional approach of removal of both tubes and ovaries at the same operation. We also compare this to the well-being of women who do not have an operation.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jul 2018 01 Jul 2025

Publications

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32907814/ protocol (added 11/09/2020)

Participants will be given the choice of which arm of the study they wish to be part of:
1. RRESDO (risk-reducing early salpingectomy and delayed oophorectomy): the new, two-stage operation (initial removal of tubes alone, followed by later removal of ovaries at a second operation after natural menopause or sooner if requested).
2. RRSO (risk-reducing salpingo-oophorectomy): removal of both tubes and ovaries at the same time. This is the current standard operation offered on the NHS to prevent ovarian cancer.
3. Controls: no operation involved.
Everyone will be required to complete questionnaires at the start of the study and annually. These ask about medical history, family history, quality of life, sexual function, cancer worry, psychological well-being and how satisfied individuals are with their decision.
All participants will also have a blood test at the start of the study and during follow up for a hormone called FSH. This will provide information on how the ovaries are functioning. Women who decide to have an operation to prevent ovarian cancer (either RRSO or RRESDO) will have a baseline ultrasound scan to look at the ovaries and a blood test for an ovarian cancer marker called CA125.
A small number of women from each study arm will be approached to take part in an optional interview. Interviews will explore views on acceptability, interest, factors influencing decision-making and willingness to undergo the new two-stage operation. Those who go on to have an operation (RRESDO/RRSO), will be contacted 1 year after their operation for a follow-up interview to discuss their satisfaction with the process and their general health and wellbeing.


Women at increased risk of developing ovarian cance, who are aged 30 years and over and have not gone through the menopause.

You can take part if:



You may not be able to take part if:


1. Previous bilateral-salpingectomy or bilateral-oophorectomy.2. Postmenopausal (amenorrhoea ≥1year (uterus in situ) / FSH >40).3. Previous tubal/ovarian/peritoneal malignancy4. <12 months post cancer treatment5. Pregnancy6. Clinical suspicion of tubal/ovarian cancer at baseline7. Inability to provide informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • East Kent Hospitals University NHS Foundation Trust
    Ethelbert Rd
    Canterbury
    CT1 3NG
  • University Hospitals of Leicester NHS Trust
    Infirmary Square
    Leicester
    LE1 5WW
  • Barts Health NHS Trust
    W Smithfield
    London
    EC1A 7BE
  • University College London Hospital Foundation Trust
    235 Euston Rd, Fitzrovia
    London
    NW1 2BU
  • Belfast Health & Social Care Trust
    Belfast
    BT9 7AB
  • Cambridge University Hospitals NHS Foundation Trust
    Hills Rd
    Cambridge
    CB2 0QQ
  • Manchester University NHS Foundation Trust
    Southmoor Rd, Wythenshawe
    Manchester
    M23 9LT
  • University Hospitals Birmingham NHS Foundation Trust
    Mindelsohn Way
    Birmingham
    B15 2TH
  • Guy’s and St Thomas’ NHS Foundation Trust
    Great Maze Pond
    London
    SE1 9RT
  • The Royal Marsden NHS Foundation Trust
    203 Fulham Rd, Chelsea
    London
    SW3 6JJ
  • Imperial College Healthcare NHS Trust
    The Bays S Wharf Rd Paddington
    London
    W2 1NY
  • Aberdeen Royal Infirmary, NHS Grampian
    Foresterhill
    Aberdeen
    AB25 2ZN
  • Maidstone and Tunbridge Wells NHS Trust
    Tonbridge Rd
    Tunbridge Wells
    TN2 4QJ
  • Norfolk and Norwich University Hospitals
    Colney Ln
    Norwich
    NR4 7UY
  • Gateshead Health NHS Foundation Trust
    Queen Elizabeth Ave
    Gateshead
    NE9 6SX
  • University Hospitals Bristol NHS Foundation Trust
    Upper Maudlin St
    Bristol
    BS2 8HW
  • Brighton and Sussex University Hospitals NHS Trust
    Eastern Rd
    Brighton
    BN2 5BE
  • Sandwell and West Birmingham Hospitals
    Dudley Rd
    Birmingham
    B18 7QH
  • Oxford University Hospitals
    Headley Way, Headington
    Oxford
    OX3 9DU
  • Ashford and St Peter’s Hospitals NHS Foundation Trust
    Guildford Rd, Lyne
    Chertsey
    KT16 0PZ
  • Cardiff and Vale NHS Trust
    Cardiff
    CF14 4XW
  • Northwick Park and St Mark's Hospitals
    Watford Rd, Harrow
    London
    HA1 3UJ
  • Portsmouth Hospitals NHS Trust
    Southwick Hill Rd, Cosham
    Portsmouth
    PO6 3LY
  • Great Ormond Street Hospital NHS Trust
    Great Ormond St
    London
    WC1N 3JH
  • Ninewells Hospital, NHS Tayside
    James Arrott Dr
    Dundee
    DD2 1SY
  • Barking, Havering and Redbridge University Hospitals NHS Trust
    Rom Valley Way
    Romford
    RM7 0AG
  • University Hospital Southampton NHS Foundation Trust
    Tremona Rd
    Southampton
    SO16 6YD

Benefits include:
1. The opportunity of having a two staged operation (RRESDO) to prevent ovarian cancer. This is not currently routinely available outside the study. It involves removal of the tubes in the first step followed by removal of ovaries at a later date.
2. Removal of the tubes alone will provide some protection against developing ovarian cancer and also preserve ovarian function which will delay or avoid early menopause. This can prevent the adverse health consequences of early menopause.
3. Participants will be given the choice of deciding which arm of the study they wish to be a part of: RRESDO (new procedure), RRSO (current standard practice), or controls (no surgery).
4. Participants will be contributing to research into preventing ovarian cancer in women at increased risk. Results of this study will help us better understand the impact of the new two stage procedure. This will help develop future clinical care guidelines and plan future care pathways for women at increased risk of ovarian cancer.
Risks:
1. Although there is evidence to suggest removal of tubes alone provides some protection against developing ovarian cancer, the precise extent of this protection is unclear. There is the possibility of getting ovarian cancer despite removal of tubes.
2. It is unclear if a possible benefit of reduced breast cancer risk is lost by not removing ovaries before menopause.
3. The two-stage option (RRESDO) involves two operations instead of one (RRSO: removal of both tubes and ovaries). Each operation has potential complications. As there are two operations this may lead to more complications overall.
4. There is concern that not everyone having their tubes removed initially will go on to have their ovaries removed at a later date. This would mean that these women who don’t do so could still remain at an increased risk of developing ovarian cancer.

Dr Ranjit Manchanda
+44 (0)7979 884575
r.manchanda@qmul.ac.uk


Dr Faiza Gaba
+44 (0)20 7882 8491
f.gaba@qmul.ac.uk



The study is sponsored by Queen Mary University of London and funded by Barts and the London Charity.



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Read full details for Trial ID: ISRCTN25173360

Or CPMS 39196

Last updated 10 March 2021

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