Can we predict the risk of cancer or precancer in postmenopausal women with polyps in their womb?
ISRCTN | ISRCTN10094287 |
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DOI | https://doi.org/10.1186/ISRCTN10094287 |
Secondary identifying numbers | 102015 |
- Submission date
- 24/05/2020
- Registration date
- 24/06/2020
- Last edited
- 04/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims:
Polyps (soft growths) within the endometrium (lining of the womb) are commonly found in women who present with abnormal vaginal bleeding or incidentally when unrelated symptoms are investigated. It is not yet clear whether all polyps should be removed by surgery in postmenopausal women. The risk of underlying cancer or pre-cancer in these polyps varies depending on a number of risk factors. The main aim of this study was to identify risk factors in order to predict cancer or pre-cancer in postmenopausal polyps.
Who can participate?
All postmenopausal women diagnosed with polyps in their womb who are not already known to have womb cancer or pre-cancer, not taking tamoxifen medication, and chose to have their polyp removed surgically.
What does the study involve?
Women with polyps are asked to answer a number of questions about their relevant medical history and they also undergo a transvaginal ultrasound scan to record information about their polyps.
What are the possible benefits and risks of participating?
There may not be any direct benefits to women. However, their participation may benefit women in the future who are considering whether to have their polyps removed or not. There is no specific risk to women who participate in our study except it is a requirement to undergo a transvaginal ultrasound examination.
Where is the study run from?
Department of Obstetrics and Gynaecology, University College London Hospitals, UK.
When is the study starting and how long is it expected to run for?
October 2015 to September 2018
Who is funding the study?
University College London (UCL) Hospitals (UK)
Who is the main contact?
Mr Davor Jurkovic, davor.jurkovic@nhs.net
Contact information
Public
Gynaecology Diagnostic and Treatment Unit
University College London Hospitals
123 Euston Road
London
NW1 2BU
United Kingdom
0000-0002-2168-1111 | |
Phone | +44 (0)20 3447 9411 |
michael.wong3@nhs.net |
Scientific
Gynaecology Diagnostic and Treatment Unit
University College London Hospitals
235 Euston Road
London
NW1 2BU
United Kingdom
0000-0002-2168-1111 | |
Phone | +44 (0)20 3447 9411 |
michael.wong3@nhs.net |
Study information
Study design | Cross-sectional observational study |
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Primary study design | Observational |
Secondary study design | Cross sectional study |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | No participant information sheet available. |
Scientific title | Risk of premalignancy or malignancy in postmenopausal endometrial polyps: a CHAID decision tree analysis |
Study objectives | It is hypothesized that patient characteristics and polyp morphological features on ultrasound can be used to predict the risk of premalignancy or malignancy in postmenopausal women. |
Ethics approval(s) | This was an observational study with no change to routine clinical practice and therefore full ethics approval or written patient consent was deemed not necessary, according to the HRA's online decision tool. |
Health condition(s) or problem(s) studied | Endometrial polyps |
Intervention | This was an observational study only. Consecutive postmenopausal women referred by their general practitioners to the outpatient gynaecology unit were potentially eligible. All women had a routine transvaginal ultrasound examination. If an endometrial polyp is diagnosed on ultrasound, the polyp's morphological features are recorded, as well as the relevant medical information about the patient. Women who chose to have surgical management of their polyps were included in the statistical analysis. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Presence or absence of premalignancy or malignancy in endometrial polyps diagnosed using transvaginal ultrasound at baseline scan |
Secondary outcome measures | Risk factors for premalignancy or malignancy in endometrial polyps were taken from the patient's medical records at the time of their clinical assessment. Patient characteristics and ultrasound morphological features were then analysed after the researchers had obtained histological diagnoses of the polyps in order to identify predictive risk factors. |
Overall study start date | 02/03/2015 |
Completion date | 02/10/2018 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | At least 200 women |
Total final enrolment | 240 |
Key inclusion criteria | 1. Postmenopausal 2. Aged 45 years or above 3. At least 1 year history of amenorrhea 4. Diagnosed with endometrial polyps on transvaginal ultrasound and underwent hysteroscopic polypectomy or hysterectomy within 2 months of the diagnosis |
Key exclusion criteria | 1. Hysterectomy 2. Known endometrial hyperplasia or cancer 3. Use of tamoxifen |
Date of first enrolment | 07/10/2015 |
Date of final enrolment | 02/10/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
235 Euston Road
London
NW1 2BU
United Kingdom
Sponsor information
Hospital/treatment centre
235 Euston Road
London
NW1 2BU
England
United Kingdom
Phone | +44 (0)20 3447 9411 |
---|---|
uclh.randd@nhs.net | |
Website | https://www.uclh.nhs.uk/Pages/home.aspx |
https://ror.org/042fqyp44 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University College London Hospitals, UCLH
- Location
- United Kingdom
Results and Publications
Intention to publish date | 01/06/2020 |
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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 | Planned publication in a peer-reviewed journal. |
IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 15/06/2021 | 04/03/2022 | Yes | No |
Editorial Notes
04/03/2022: Publication reference and total final enrolment added.