NCT06907550Not yet recruiting
Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
Source: ClinicalTrials.gov · Last updated 13 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- Apr 2025
- Primary completion date
- Apr 2030
- Lead sponsor
- Pearsanta, Inc
- Diseases
- Endometriosis
- NCT number
- NCT06907550
What you commit to
- Study type: Observational
- Planned participants: 1000
- From Apr 2025 to the primary completion date, Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has had a prior surgical diagnosis of endometriosis at time of blood collection
Other illness
- 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
Other
- Is unable to communicate in written and spoken English
Who the study is looking for
- 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
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pearsanta, Inc. Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.