Investigation of the diagnostic accuracy of a new blood test for endometriosis, compared with the current gold standard surgery for diagnosis

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13298303

Enrollment

600

Registered

2020-11-03

Start date

2026-01-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis Urological and Genital Diseases Endometriosis

Interventions

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 contrib

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactRobert Poulter

r.poulter@mdnalifesciences.com+1 844-321-6362

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026