Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of… (NCT06907550) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
United States1,000 participantsStarted 2025-04
Plain-language summary
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.
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.
Who can participate
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Has had a prior surgical diagnosis of endometriosis at time of blood collection
. Is unable to communicate in written and spoken English
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.