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Blood Test to Help Detect Endometriosis in Women With Symptoms

Tests a blood test for endometriosis in women referred for keyhole surgery.

Key facts

Who runs it
Pearsanta, Inc
Where
Richmond, United StatesSee the site
Trial code
Registry title
Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
Status
Not yet recruiting
People taking part
1,000 people, planned
Started
Apr 2025
Expected to end
Apr 2030
Type of study
Observational
Treatments tested
  • The Mitomic Endometriosis Test (MET) blood test for early detection of endometriosis
Record updated
13 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with symptoms of endometriosis who are due to have their first keyhole surgery (laparoscopy) to find out if they have it. A blood test is compared with the surgery result.

Age
Women between their first period (menarche) and menopause. No exact ages are given.
Sex
Female only.
Disease stage
Symptoms of endometriosis, with a first laparoscopy planned to diagnose it.
Earlier treatment
A blood sample must be given before the surgery and before surgery-related drugs such as anaesthetics or antibiotics. No earlier surgical diagnosis of endometriosis.
Biomarker or test result
The Mitomic Endometriosis Test (MET) is run on the blood sample. No test result is needed to join.

Main reasons for not taking part

  • Already had a surgical diagnosis of endometriosis when the blood is taken
  • Cannot communicate in written and spoken English
  • Not fit to undergo all procedures in the protocol
  • Cannot give written informed consent
  • Another condition that, in the investigator's opinion, makes joining unsuitable

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Be female, between menarche and menopause who present with symptoms of endometriosis at time of blood collection and are scheduled to undergo their first laparoscopic procedure for the diagnosis of endometriosis
  • Provide a blood sample prior to surgical procedure or administration of drugs related to the surgical procedure (i.e. anaesthetics, antibiotics)
  • Be fit to undergo all procedures listed in protocol
  • Be able to provide written informed consent

Who cannot take part

  • Has had a prior surgical diagnosis of endometriosis at time of blood collection
  • Has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study. This reason must be recorded on the CRF
  • Is unable to communicate in written and spoken English

Where in United States

  • Pearsanta, Inc.Richmond, United StatesContact: Stephen VarvelNot yet recruiting

About the trial

What the trial wants to find out

This study will investigate the clinical performance and diagnostic accuracy of the Mitomic® Endometriosis Test (MET) compared to laparoscopic diagnosis in a prospective clinical study in females presenting with symptoms suggestive of endometriosis. This study will recruit patients with suspected endometriosis who have been referred for a diagnostic laparoscopy. Patients will complete a questionnaire about their endometriosis symptoms and a sample of blood will be taken prior to their laparoscopy and sent to the laboratory for the MET to be run.

Read full original descriptionShow less

This study aims to first enroll 104 subjects to support the clinical validation necessary for launch of the test as an LDT. Following this, we plan a study extension with an aim to enroll up to 900 more (for a total of 1000) subjects to enable more precise estimation of performance characteristics, characterization of test performance in subtypes of endometriosis, to better understand the relationship between test results and secondary endpoints such as symptoms and demographic variables, and to establish a bank of samples to support future test development.

The group in the trial

  • Females suspected of endometriosis scheduled for laparoscopic surgery

    Treatment: The Mitomic Endometriosis Test (MET) blood test for early detection of endometriosis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
Plain-language title
Blood Test to Help Detect Endometriosis in Women With SymptomsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 April 2025