Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Michael Wong
ORCID ID
https://orcid.org/0000-0002-2168-1111
Contact details
Gynaecology Diagnostic and Treatment Unit
University College London Hospitals
123 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)20 3447 9411
michael.wong3@nhs.net
Type
Scientific
Additional contact
Dr Michael Wong
ORCID ID
https://orcid.org/0000-0002-2168-1111
Contact details
Gynaecology Diagnostic and Treatment Unit
University College London Hospitals
235 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)20 3447 9411
michael.wong3@nhs.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
102015
Study information
Scientific title
Risk of premalignancy or malignancy in postmenopausal endometrial polyps: a CHAID decision tree analysis
Acronym
Study hypothesis
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
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.
Study design
Cross-sectional observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
No participant information sheet available.
Condition
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
Phase
Drug names
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 trial start date
02/03/2015
Overall trial end date
02/10/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
At least 200 women
Participant exclusion criteria
1. Hysterectomy
2. Known endometrial hyperplasia or cancer
3. Use of tamoxifen
Recruitment start date
07/10/2015
Recruitment end date
02/10/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London Hospitals
Gynaecology Diagnostic and Treatment Unit
235 Euston Road
London
NW1 2BU
United Kingdom
Sponsor information
Organisation
University College London Hospitals NHS Foundation Trust
Sponsor details
235 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)20 3447 9411
uclh.randd@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University College London Hospitals NHS Foundation Trust
Alternative name(s)
UCLH
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a peer-reviewed journal.
IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/06/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list