DAMET - RWE
Research type
Research Study
Full title
Investigation of the diagnostic accuracy of the Mitomic Endometriosis Test (MET) - Real World Evidence in the NHS.
IRAS ID
278047
Contact email
Sponsor organisation
MDNA Life Sciences Inc.
ISRCTN Number
ISRCTN13298303
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The DAMET-RWE trial will assess if 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. We aim 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.
Participants who have already been referred for their first laparoscopy to diagnose suspected endometriosis by their consultant will be recruited for this study. 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 data collected will show the capability of the MET™ in: 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 correlation between MET™ result and: presenting symptom(s), hormone status, age at diagnosis and age of first report of symptoms.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/1185
Date of REC Opinion
16 Feb 2021
REC opinion
Further Information Favourable Opinion