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Contact Information:

Dr . PROTECTOR Study Team
bci-protector@qmul.ac.uk


Dr Ranjit Manchanda
r.manchanda@qmul.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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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

Early removal of Fallopian tubes and delayed removal of ovaries in women at high risk of ovarian cancer

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 PROTECTOR study aims to find out how many ovarian cancers happen after removing the tubes. This will help us assess how effective having just the tubes removed is for reducing the risk of ovarian cancer (i.e. what the precise level of ovarian cancer risk reduction is). This would help policy makers to decide whether this two-step procedure (RRESDO) should be recommended in routine clinical practice. The study will also carry out an economic evaluation to see whether this is affordable for the NHS.
The PROTECTOR study will also assess people’s views and the impact of this two-step procedure on sexual function, hormone levels, quality of life and overall satisfaction. We will compare RRESDO to the traditional approach of removing both the tubes and ovaries in the same operation (RRSO). We will also compare this to the well-being of individuals who choose not to 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 31 Jul 2030

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 cancer, who are aged 30 years and over and have not gone through the menopause.

You can take part if:


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


You may not be able to take part if:


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 malignancy4. <3 months post cancer treatment5. Pregnancy6. Clinical suspicion of tubal/ovarian cancer at baseline7. Inability to provide informed consent

_____

Previous 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 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.

  • South Tees Hospitals NHS Foundation Trust
    James Cook University Hospital Marton Road
    Middlesbrough
    TS4 3BW
  • Royal Surrey County Hospital
    Egerton Road
    Guildford
    GU2 7XX
  • NHS Greater Glasgow and Clyde
    J B Russell House Gartnavel Royal Hospital 1055 Great Western Road Glasgow
    Glasgow
    G12 0XH
  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
    Nottingham University Hospital Derby Road
    Nottingham
    NG7 2UH
  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • Northampton General Hospital NHS Trust
    Cliftonville
    Northampton
    NN1 5BD
  • Royal United Hospitals Bath NHS Foundation Trust
    Combe Park
    Bath
    BA1 3NG
  • East Lancashire Hospitals NHS Trust
    Royal Blackburn Hospital Haslingden Road
    Blackburn
    BB2 3HH
  • Royal Victoria Infirmary
    Queen Victoria Road
    Newcastle Upon Tyne
    NE1 4LP
  • Royal Derby Hospital
    Uttoxeter Road
    Derby
    DE22 3NE
  • Royal Cornwall Hospitals NHS Trust
    Royal Cornwall Hospital Treliske
    Truro
    TR1 3LJ
  • Royal Infirmary of Edinburgh at Little France
    51 Little France Crescent Old Dalkeith Road Edinburgh
    Lothian
    EH16 4SA
  • Worcestershire Acute Hospitals NHS Trust
    Worcestershire Royal Hospital Charles Hastings Way
    Worcester
    WR5 1DD
  • East Kent Hospitals University NHS Foundation Trust
    Ethelbert Rd
    Canterbury
    CT1 3NG
  • North Tees and Hartlepool NHS Foundation Trust
    University Hospital of Hartlepool Holdforth Road
    Hartlepool
    TS24 9AH
  • Ysbyty Gwynedd Hospital (yg NHS Trust)
    Ysbyty Gwynedd Penrhosgarnedd
    Bangor
    LL57 2PW
  • University Hospitals of Leicester NHS Trust
    Infirmary Square
    Leicester
    LE1 5WW
  • Liverpool Women's NHS Foundation Trust
    Liverpool Womens Hospital Crown Street
    Liverpool
    L8 7SS
  • County Durham and Darlington NHS Foundation Trust
    Darlington Memorial Hospital Hollyhurst Road
    Darlington
    DL3 6HX
  • Cambridge University Hospitals NHS Foundation Trust
    Addenbrooke's Hospital Hills Rd
    Cambridge
    CB2 0QQ
  • University College London Hospital Foundation Trust
    235 Euston Rd, Fitzrovia
    London
    NW1 2BU
  • Belfast Health & Social Care Trust
    Belfast
    BT9 7AB
  • Manchester University NHS Foundation Trust
    Southmoor Rd, Wythenshawe
    Manchester
    M23 9LT
  • Guy’s and St Thomas’ NHS Foundation Trust
    Great Maze Pond
    London
    SE1 9RT
  • 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
  • Oxford University Hospitals
    Headley Way, Headington
    Oxford
    OX3 9DU
  • 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
  • Ninewells Hospital, NHS Tayside
    James Arrott Dr
    Dundee
    DD2 1SY
  • University Hospital Southampton NHS Foundation Trust
    Tremona Rd
    Southampton
    SO16 6YD
  • Barts Health NHS Trust
    Royal London Hospital
    London
    E1 1FR
  • Sandwell and West Birmingham Hospitals NHS Trust
    Midland Metropolitan University Hos Grove Lane
    Smethwick
    B66 2QT
  • St George's University Hospitals NHS Foundation Trust
    Blackshaw Road Tooting
    London
    SW17 0QT
  • Royal Devon and Exeter Hospital
    Gladstone Road
    Exeter
    EX1 2ED

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 . PROTECTOR Study Team
bci-protector@qmul.ac.uk


Dr Ranjit Manchanda
r.manchanda@qmul.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


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 14 October 2025

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