Can we predict the risk of cancer or precancer in postmenopausal women with polyps in their womb?

ISRCTN	ISRCTN10094287
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Michael Wong
Public

Gynaecology Diagnostic and Treatment Unit
University College London Hospitals
123 Euston Road
London
NW1 2BU
United Kingdom

ORCID ID	0000-0002-2168-1111
Phone	+44 (0)20 3447 9411
Email	michael.wong3@nhs.net

Dr Michael Wong
Scientific

Gynaecology Diagnostic and Treatment Unit
University College London Hospitals
235 Euston Road
London
NW1 2BU
United Kingdom

ORCID ID	0000-0002-2168-1111
Phone	+44 (0)20 3447 9411
Email	michael.wong3@nhs.net

Study information

Study design	Cross-sectional observational study
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
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

University College London Hospitals

Gynaecology Diagnostic and Treatment Unit
235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust
Hospital/treatment centre

235 Euston Road
London
NW1 2BU
England
United Kingdom

Phone	+44 (0)20 3447 9411
Email	uclh.randd@nhs.net
Website	https://www.uclh.nhs.uk/Pages/home.aspx
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Hospital/treatment centre

University College London Hospitals NHS Foundation Trust
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
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.