Developing tests for endometrial cancer detection
| ISRCTN | ISRCTN58863784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58863784 |
| Secondary identifying numbers | R04415 |
- 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
Plain English summary of protocol
Contact information
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 |
|---|---|
| suzanne.carter@manchester.ac.uk |
Scientific
Division of Cancer Sciences
University of Manchester
St Mary’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Prospective multicentre double-blind diagnostic test accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Diagnostic test accuracy study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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 |
| Secondary outcome measures | 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. |
| Overall study start date | 07/06/2018 |
| Completion date | 31/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centres
Manchester
M13 9WL
United Kingdom
Bury
BL9 7TD
United Kingdom
Manchester
OL1 2JH
United Kingdom
Crumpsall
Manchester
M8 5RB
United Kingdom
Ashton under Lyne
OL6 9RW
United Kingdom
Manchester
M23 9LT
United Kingdom
Davyhulme
Manchester
M41 5SL
United Kingdom
Sponsor information
Hospital/treatment centre
St Mary's Hospital
Oxford Road
Manchester
M13 9WL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| 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 |
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.
