Condition category
Urological and Genital Diseases
Date applied
06/10/2020
Date assigned
03/11/2020
Last edited
05/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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 December 2023

Who is funding the study?
MDNA Life Sciences (USA)

Who is the main contact?
Dr Stephanie Tweed
stephanie.tweed@aspirepharma.co.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Stephanie Tweed

ORCID ID

Contact details

Aspire Pharma Limited
Unit 4 Rotherbrook Court
Bedford Road
Petersfield
GU32 3QG
United Kingdom
+44 (0)1730 231148
clinicaltrials@aspirepharma.co.uk

Type

Scientific

Additional contact

Dr Stephanie Tweed

ORCID ID

Contact details

Aspire Pharma Limited
Unit 4 Rotherbrook Court
Bedford Road
Petersfield
GU32 3QG
United Kingdom
+44 (0)1730 231148
clinicaltrials@aspirepharma.co.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

TF020-CIP1, IRAS 278047

Study information

Scientific title

Investigation of the diagnostic accuracy of the Mitomic® Endometriosis Test (MET™) – real world evidence in the NHS

Acronym

DAMET-RWE

Study hypothesis

The Mitomic Endometriosis Test (MET™) is as good at diagnosing endometriosis as a laparoscopy.

Ethics approval

Approval pending

Study design

Multicentre non-interventional real-world evidence study

Primary study design

Observational

Secondary study design

Diagnostic accuracy study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional files

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

Phase

Drug names

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 trial start date

01/01/2020

Overall trial end date

31/12/2023

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

600

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

01/12/2020

Recruitment end date

01/12/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's Hospital
Mindelsohn Way
Birmingham
B15 2TG
United Kingdom

Trial participating centre

Colchester General Hospital
Abbey Wing St Peters Hospital Guildford Road
Colchester
KT16 0PZ
United Kingdom

Trial participating centre

Burnley General Teaching Hospital
Casterton Avenue
Burnley
BB10 2PQ
United Kingdom

Trial participating centre

University College Hospital
Elizabeth Garrett Anderson Wing University College Hospital 25 Grafton Way Fitzrovia
London
WC1E 6DB
United Kingdom

Trial participating centre

Southmead Hospital
Redland Hill Redland Durdham Down
Bristol
BS6 6UT
United Kingdom

Trial participating centre

Hampshire Endometriosis Centre
Princess Anne Hospital University Hospital Southampton Coxford Rd
Southampton
SO16 5YA
United Kingdom

Trial participating centre

East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom

Trial participating centre

Queen Elizabeth University Hospital
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Trial participating centre

University Hospital Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
51 Little France Crescent Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Liverpool Women’s NHS Foundation Trust
Crown Street
Liverpool
L8 7SS
United Kingdom

Sponsor information

Organisation

MDNA Life Sciences

Sponsor details

2054 Vista Parkway
Suite 400
West Palm Beach
FL 33411
United States of America
+1 (0) 844 321 662
j.creed@mdnalifesciences.com

Sponsor type

Industry

Website

https://mdnalifesciences.com/

Funders

Funder type

Industry

Funder name

MDNA Life Sciences

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.