Developing tests for endometrial cancer detection

ISRCTN	ISRCTN58863784
DOI	https://doi.org/10.1186/ISRCTN58863784
Protocol serial number	R04415
Sponsor	Manchester University Hospital NHS Foundation Trust
Funder	The Jon Moulton Charity Trust

Submission date: 02/08/2018
Registration date: 09/08/2018
Last edited: 11/04/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-a-new-test-for-womb-cancer-detect

Contact information

Miss Suzanne Carter
Public

Division of Cancer Sciences
University of Manchester
St Mary’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Phone	+44 (0)161 701 6912
Email	suzanne.carter@manchester.ac.uk

Dr Emma Crosbie
Scientific

Division of Cancer Sciences
University of Manchester
St Mary’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Study information

Primary study design	Observational
Study design	Prospective multicentre double-blind diagnostic test accuracy study
Secondary study design	Diagnostic test accuracy study
Study type	Participant information sheet
Scientific title	DEveloping Tests for Endometrial Cancer deTection
Study acronym	DETECT Multicentre
Study objectives	The aim of the study is to establish the diagnostic test accuracy of urogenital cytology for endometrial cancer detection in women with unexplained postmenopausal bleeding.
Ethics approval(s)	North West - Greater Manchester West Research Ethics Committee, 27/06/2018, ref: 16/NW/0660
Health condition(s) or problem(s) studied	Endometrial cancer
Intervention	After written informed consent, the trialists will obtain medical history and matched urine and vaginal samples from women with unexplained postmenopausal bleeding. Urine samples will be self collected in a sterile pot and vaginal samples will be taken by a research practitioner using a Delphi screener according to a strict protocol. The urine and vaginal samples will then be transferred to the cytopathology department at Manchester University NHS Foundation Trust for cytological assessment. The accuracy of urogenital cytology will be measured against standard diagnostic tests for endometrial cancer.
Intervention type	Other
Primary outcome measure(s)	Sensitivity: the proportion of women who have endometrial cancer who test positive by urogenital cytology (true positive rate) and negative predictive value – the proportion of test negatives who are true negatives. The accuracy of urine +/- vaginal cytology (index test) will be defined by the results of standard endometrial cancer diagnostic tests
Key secondary outcome measure(s)	1. Specificity: the proportion of women who do not have endometrial cancer who test negative by urogenital cytology (true negative rate) 2. False positive/negative rates (including clinical scenarios associated with these) 3. Positive predictive value 4. Test acceptability (short questionnaire to compare acceptability of urogenital cytology with standard diagnostic tests) Exploratory analyses beyond the scope of this study: The trialists will collect the residual urogenital cytology samples and store them in the MFT Biobank for future biomarker discovery work. They will centrifuge the samples to pellet the cellular material and freeze the pellet plus an aliquot of the supernatant.
Completion date	31/10/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	2000
Total final enrolment	1890
Key inclusion criteria	1. Women with unexplained postmenopausal bleeding attending for urgent investigations to exclude endometrial cancer 2. Written informed consent to participate
Key exclusion criteria	Current exclusion criteria as of 21/12/2018: 1. Abnormal bleeding before the menopause (in whom the risk of cancer is much lower) 2. Previous diagnosis of endometrial cancer 3. Previous hysterectomy 4. Mirena coil in situ or removed within the last 3 months 5. Any other condition that would compromise participant safety or data integrity Previous exclusion criteria: 1. Abnormal bleeding before the menopause (in whom the risk of cancer is much lower) 2. Previous diagnosis of endometrial cancer 3. Previous hysterectomy
Date of first enrolment	03/09/2018
Date of final enrolment	01/09/2021

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

St Mary's Hospital

Oxford Road
Manchester
M13 9WL
United Kingdom

Fairfield General Hospital

Rochdale Old Road
Bury
BL9 7TD
United Kingdom

Royal Oldham Hospital

Rochdale Road
Manchester
OL1 2JH
United Kingdom

North Manchester General Hospital

Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom

Tameside General Hospital

Fountain Street
Ashton under Lyne
OL6 9RW
United Kingdom

Wythenshawe Hospital

Southmoor Road
Manchester
M23 9LT
United Kingdom

Trafford General Hospital

Moorside Road
Davyhulme
Manchester
M41 5SL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Emma Crosbie (emma.crosbie@manchester.ac.uk). The consent form was adapted to include a specific clause to share anonymised data. Early versions may not include this.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		28/07/2021	21/09/2021	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2023: IPD sharing statement added.
04/04/2023: The intention to publish date was changed from 01/04/2023 to 01/10/2023.
11/10/2022: The intention to publish date was changed from 01/09/2022 to 01/04/2023.
21/10/2021: The total final enrolment number has been added.
21/09/2021: Publication reference added.
03/09/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/09/2020 to 01/09/2021.
2. The overall trial end date was changed from 07/09/2020 to 31/10/2021.
3. The intention to publish date was changed from 01/09/2021 to 01/09/2022.
4. Recruitment to this study is no longer paused.
12/05/2020: Internal review.
24/04/2020: Due to current public health guidance, recruitment for this study has been paused.
21/12/2018: The following changes have been made:
1. Wythenshawe Hospital and Trafford General Hospital were added as trial participating centres.
2. The participant exclusion criteria have been changed.
23/11/2018: Cancer Research UK lay summary link added to plain English summary field.
11/09/2018: Tameside General Hospital was added as a trial participating centre
13/08/2018: Fairfield General Hospital, Royal Oldham Hospital and North Manchester General Hospital were added as trial participating centres.