Investigation of the diagnostic accuracy of a new blood test for endometriosis, compared with the current gold standard surgery for diagnosis
| ISRCTN | ISRCTN13298303 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13298303 |
| IRAS number | 278047 |
| Secondary identifying numbers | TF020-CIP1, IRAS 278047 |
- Submission date
- 06/10/2020
- Registration date
- 03/11/2020
- Last edited
- 20/12/2024
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Endometriosis is a disorder in which tissue similar to the tissue that forms the lining of the uterus grows outside of the uterine cavity. The study will assess whether a new blood test, called the ‘Mitomic® Endometriosis Test’ or MET™ for short, can diagnose endometriosis as effectively as the current procedure used for diagnosis, an operation called a laparoscopy. Endometriosis has similar symptoms to other diseases, so up to 50% of patients who have the operation find out they do not have endometriosis. The aim is to find out if the blood test could be used to confirm or rule out a diagnosis of endometriosis, without the patient needing an operation. On the other hand, being able to rule in endometriosis as a possibility in those patients who have symptoms will speed up their access to appropriate treatment and care.
Who can participate?
Female patients who have been referred for their first laparoscopy to diagnose suspected endometriosis
What does the study involve?
Participants will need to give an extra blood sample at their pre-operation visit and this will be sent away to a laboratory where it can be tested using the MET™. The laparoscopy operation will continue as normal - the operating clinician will provide details about the type and extent of endometriosis seen during the surgery. Participants will also be asked to complete a short questionnaire about their symptoms and to complete a recovery diary after their laparoscopy. The trial aims to include 600 patients who will be recruited across about 12 participating sites over about 1 year.
What are the possible benefits and risks of participating?
The data collected will show the capability of the MET™ at predicting the presence or absence of endometriosis, identifying endometriosis subtypes (primary peritoneal, endometrioma, deep infiltrating endometriosis) and stages of endometriosis (Stage 1, 2, 3, 4 and 1/2, 3/4). The data will also determine if there is a correlation between the MET™ result and presenting symptom(s), hormone status, age at diagnosis and age of the first report of symptoms. This study is being sponsored and funded by MDNA Life Sciences who developed the MET and the data will be used to obtain a CE mark and shown to healthcare payers (the NHS) to demonstrate the effectiveness of the MET.
The benefits conferred by this study are purely altruistic - if the results lead to the inclusion of MET in the NHS diagnostic pathway for endometriosis, then future patients may be diagnosed more quickly and may not have to have invasive surgery where it will not benefit them. The physical risk to patients in participating is minimal due to the non-interventional design of the study. The only additional clinical step is the donation of a blood sample and as the patient will be having blood tests before their surgery the additional risk is considered minimal. No decision about the care of the patient will be made based on the MET results so participation in the study will have no effect on the treatment.
Where is the study run from?
MDNA Life Sciences (USA)
When is the study starting and how long is it expected to run for?
January 2020 to May 2027
Who is funding the study?
MDNA Life Sciences (USA)
Who is the main contact?
Robert Poulter, r.poulter@mdnalifesciences.com
Contact information
Public
Chief Business Officer
MDNA Life Sciences UK
The Biosphere
Newcastle Helix
Draymans Way
Newcastle upon Tyne
NE4 5BX
United Kingdom
| Phone | +1 844-321-6362 |
|---|---|
| r.poulter@mdnalifesciences.com |
Study information
| Study design | Multicentre non-interventional real-world evidence study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Diagnostic accuracy study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN13298303_PIS_V1.0_28Aug20.pdf |
| Scientific title | Investigation of the diagnostic accuracy of the Mitomic® Endometriosis Test (MET™) – real world evidence in the NHS |
| Study acronym | DAMET-RWE |
| Study hypothesis | The Mitomic Endometriosis Test (MET™) is as good at diagnosing endometriosis as a laparoscopy. |
| Ethics approval(s) | Approval pending |
| Condition | Endometriosis |
| Intervention | Patients who are being referred for a diagnostic laparoscopy for suspected endometriosis will also have a blood test using MET and the results will be compared. The results of the MET will not contribute to future decisions regarding the patient's care. |
| Intervention type | Other |
| Primary outcome measure | The diagnostic accuracy of the Mitomic® Endometriosis Test (MET™), assessed by comparing the test results with the results of a laparoscopy (current standard of care), measured at a single timepoint |
| Secondary outcome measures | Measured at a single timepoint: 1. The diagnostic accuracy of MET™ for: 1.1. Different endometriosis subtypes (primary peritoneal, endometrioma, deep infiltrating endometriosis) 1.2. Different stages of endometriosis (Stage 1, 2, 3, 4 and 1/2, 3/4) Assessed by comparing the MET results with the results from the laparoscopy. 2. Correlations between MET™ result and 2.1. Presenting symptom(s) assessed using patient questionnaire 2.2. Hormone status assessed using patient questionnaire 2.3. Age at diagnosis assessed using patient questionnaire 2.4. Age of first report of symptom assessed using patient questionnaire 3. The impact of laparoscopic surgery on quality of life measured using a patient diary in the immediate postoperative period |
| Overall study start date | 01/01/2020 |
| Overall study end date | 01/05/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 600 |
| Participant inclusion criteria | 1. Female between menarche and menopause who are scheduled to undergo their first laparoscopic procedure for suspected endometriosis 2. Willing and able to provide an additional blood sample via venepuncture prior to the surgical procedure or administration of any presurgical medications (e.g. at the time of routine pre-operative bloods being taken and in all cases before the start of administering general anaesthesia) 3. Fit to undergo all procedures listed in protocol 4. Able to provide written informed consent |
| Participant exclusion criteria | 1. A prior surgical diagnosis of endometriosis 2. Any contraindication to laparoscopy under general anaesthesia 3. Taking antibiotics or have taken antibiotics in the last 2 weeks |
| Recruitment start date | 01/01/2026 |
| Recruitment end date | 01/01/2027 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Birmingham
B15 2TG
United Kingdom
St Peters Hospital
Guildford Road
Colchester
KT16 0PZ
United Kingdom
Burnley
BB10 2PQ
United Kingdom
University College Hospital
25 Grafton Way
Fitzrovia
London
WC1E 6DB
United Kingdom
Redland
Durdham Down
Bristol
BS6 6UT
United Kingdom
University Hospital Southampton
Coxford Rd
Southampton
SO16 5YA
United Kingdom
Redhill
RH1 5RH
United Kingdom
Glasgow
G51 4TF
United Kingdom
Scunthorpe
DN15 7BH
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
Liverpool
L8 7SS
United Kingdom
Sponsor information
Industry
2054 Vista Parkway
Suite 400
West Palm Beach
FL 33411
United States of America
| Phone | +1 (0) 844 321 662 |
|---|---|
| j.creed@mdnalifesciences.com | |
| Website | https://mdnalifesciences.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/05/2028 |
|---|---|
| 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 of results in a suitable peer-reviewed journal. No other documents will be available. Results will not be shared with participants directly - patients will receive their laparoscopy results and positive or negative diagnosis for endometriosis in line with normal clinical practice. The MET results will likely not be available until after the diagnosis has been made and as such will not be of use to the clinician or patient. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.0 | 28/08/2020 | 05/11/2020 | No | Yes |
Additional files
- ISRCTN13298303_PIS_V1.0_28Aug20.pdf
- uploaded 05/11/2020
Editorial Notes
20/12/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 02/08/2021 to 01/01/2026.
2. The recruitment end date was changed from 01/01/2026 to 01/01/2027.
11/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 01/01/2024 to 01/01/2026.
2. The overall study end date was changed from 01/05/2025 to 01/05/2027.
3. The intention to publish date was changed from 01/05/2026 to 01/05/2028.
09/01/2024: Contact details updated.
30/08/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2022 to 01/01/2024.
2. The overall end date was changed from 31/12/2023 to 01/05/2025.
3. The intention to publish date was changed from 31/12/2024 to 01/05/2026.
4. The contact was updated.
5. The plain English summary was updated to reflect these changes.
23/08/2022: Internal review.
08/04/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/12/2020 to 02/08/2021.
2. The recruitment end date was changed from 01/12/2021 to 31/08/2022.
05/11/2020: The participant information sheet was uploaded as an additional file.
28/10/2020: Trial's existence confirmed by the Health Research Authority.
