Condition category
Urological and Genital Diseases
Date applied
24/05/2020
Date assigned
24/06/2020
Last edited
22/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www.uclh.nhs.uk/Pages/home.aspx

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

Publication citations

Additional files

Editorial Notes