Views of women at increased risk of ovarian cancer towards removal of fallopian tubes for ovarian cancer prevention
| ISRCTN | ISRCTN12310993 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12310993 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 08/02/2018
- Registration date
- 09/02/2018
- Last edited
- 20/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Ovarian cancer is the main cause of death from gynaecological malignancies in the UK. Despite massive funding in developing drugs and new treatment strategies, survival rates remain much poorer when compared to other cancers with 3 in 10 women alive at 10 years. In addition, 1 in 10 of all ovarian cancer is familial and most commonly caused by a fault/alteration in the BRCA1 or BRCA2 gene. BRCA1/BRCA2 carriers have a 17-44% risk over their life of developing ovarian cancer and 65-72% risk of developing breast cancer. This is much higher than for women who do not carry the gene who have a 1 in 50 (2%) and a 1 in 8 (12%) lifetime risk of developing ovarian and breast cancer respectively. Focusing on developing strategies to prevent ovarian cancer in women at increased risk may have a significant impact on disease burden. There is currently no screening programme for ovarian cancer available on the NHS unlike other female cancers such as cervical and breast cancer. The current practice is to offer women who are at increased risk, once they have completed their family, surgery to remove their fallopian tubes and ovaries. This procedure is called risk reducing salpingo-oophorectomy (RRSO). This significantly reduces the risk of ovarian cancer by 90% but leads to early menopause. This has serious implications on a woman's general health. Not only does early menopause result in menopausal type symptoms such as hot flushes, changes in mood and pain during intercourse, it also increases the risk of osteoporosis (brittle bones), heart disease, stroke and dementia. Current research suggests that many cancers of the ovary actually start in the fallopian tube. This has led to the proposal of an alternative strategy which involves offering women surgery in two stages. The first operation involves removing the fallopian tubes. The second operation involves removing the ovaries after the patient has gone through the menopause (average age 51 in the UK). The advantage of this new surgical prevention strategy is that it offers some protection against ovarian cancer in young women whilst avoiding the negative health consequences of early menopause which can have a significant impact on quality of life. At present the precise level of benefit obtained from removing the tubes alone is not known. There are no research studies to show whether this two-stage procedure is acceptable and effective for preventing ovarian cancer. Further research is needed to establish this. The aim of this study is to collect the views of women at increased risk on this ‘two-stage’ strategy to prevent ovarian cancer.
Who can participate?
Women aged over 18, living in the UK who are at increased risk of developing tubal/ovarian cancer because they carry an alteration/fault in the BRCA1/BRCA2/RAD51C/RAD51D/BRIP1 gene or have a strong family history of breast and ovarian cancer or ovarian cancer alone
What does the study involve?
Participants complete an online or paper questionnaire to gather information about their attitudes towards the two-staged surgical approach to reduce the risk of ovarian cancer. The questionnaire is conducted just once per participant. There are no follow up questionnaires.
What are the possible benefits and risks of participating?
Participants will help researchers understand how women feel about this new two-staged surgical approach of preventing ovarian cancer. It will help develop future research studies for ovarian cancer prevention and benefit the health of women at increased risk of ovarian cancer in the future. The drawback to participating is the inconvenience of completing a questionnaire.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
October 2017 to March 2020
Who is the main contact?
1. Dr Ranjit Manchanda (scientific)
r.manchanda@qmul.ac.uk
2. Dr Faiza Gaba (public)
f.gaba@qmul.ac.uk
Contact information
Scientific
Barts Cancer Institute, Room 4, Basement, Old Anatomy Building
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
 ORCID ID |
0000-0003-3381-5057 |
|---|---|
| Phone | +44 (0)7979884575 |
| r.manchanda@qmul.ac.uk |
Public
Barts Cancer Institute, ECMC
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| ORCID ID |
0000-0003-4081-6883 |
|---|---|
| Phone | +44 (0)2078828491 |
| f.gaba@qmul.ac.uk |
Study information
| Study design | Prospective cohort survey study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Survey to determine attitudes of women at high risk of ovarian cancer towards Risk Reducing Early Salpingectomy and Delayed Oophorectomy (RRESDO) for ovarian cancer prevention |
| Study objectives | Risk reducing early salpingectomy with delayed oophorectomy is an acceptable surgical prevention strategy for women who are at increased risk of ovarian cancer. |
| Ethics approval(s) | West Midlands - Edgbaston Research Ethics Committee, 21/08/2017, REC ref: 17/WM/0324 |
| Health condition(s) or problem(s) studied | Prevention of ovarian cancer |
| Intervention | Participants who have met the study's inclusion/exclusion criteria and who have provided informed consent will be given a questionnaire to complete. This will gather information about their attitudes towards a novel two staged surgical approach (risk reducing early salpingectomy with delayed oophorectomy) to reduce the risk of ovarian cancer. The questionnaire may be completed online or using a paper version. The questionnaire is conducted just once per participant. There are no follow up questionnaires. |
| Intervention type | Other |
| Primary outcome measure | Awareness and interest in an early salpingectomy and delayed oophorectomy strategy for ovarian cancer prevention, measured using a questionnaire at a single timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 30/10/2017 |
| Completion date | 01/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Up to 1000 |
| Total final enrolment | 683 |
| Key inclusion criteria | Current inclusion criteria as of 09/05/2018: 1. Women ≥18 years 2. At increased risk of developing ovarian cancer due to BRCA1/BRCA2/RAD51C/RAD51D/BRIP1 mutation or on the basis of a strong family history of ovarian cancer alone or breast and ovarian cancer 3. Resident in the UK 4. Able to provide written informed consent Previous inclusion criteria: 1. Women ≥18 years 2. At increased risk of developing ovarian cancer due to BRCA1/BRCA2 mutation or on the basis of family history 3. Resident in the UK 4. Able to provide written informed consent |
| Key exclusion criteria | 1. Prior or current diagnosis of tubal/ ovarian/primary peritoneal cancer 2. Inability to read or write |
| Date of first enrolment | 04/01/2018 |
| Date of final enrolment | 04/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
West Smithfield
London
EC1A 7BE
United Kingdom
Fitzrovia
London
NW1 2BU
United Kingdom
Sponsor information
University/education
Joint Research Management Office
5 Walden Street
London
E1 2EF
England
United Kingdom
| Phone | +44 (0)20 7882 7260 |
|---|---|
| sponsorsrep@bartshealth.nhs.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Additional documents e.g. protocol are not published. They will not be made available unless specific requests for additional information are made to the chief investigator Ranjit Manchanda in writing. Results of the research will be presented at scientific conferences and published in scientific journals. They will also be made available through cancer charities, patient support groups and the Queen Mary University of London website. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2021 | 20/01/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/01/2021: Publication reference added.
03/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2019 to 04/06/2019.
2. The total final enrolment was added.
08/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 01/12/2018 to 01/06/2019.
2. The intention to publish date has been updated from 01/12/2019 to 01/12/2020.
09/05/2018: The inclusion criteria were updated.
