Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis

NCT06907550 | Not Yet Recruiting FDA Device

• 1 other identifier: R2025-1001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Presence or absence of endometriosis

  Presence or absence of endometriosis as determined by standard-of-care diagnostic laparoscopy

  up to 5 years

Study Arms (1)

Females suspected of endometriosis scheduled for laparoscopic surgery

Females suspected of endometriosis scheduled for laparoscopic surgery

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

Interventions

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

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 testing.

Females suspected of endometriosis scheduled for laparoscopic surgery

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Females between menarche and menopause presenting with symptoms suggestive of endometriosis and scheduled for a standard-of-care diagnostic laparoscopy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearsanta, Inc: lead

Study Sites (1)

Pearsanta, Inc.

Richmond, Virginia, 23219, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Endometriosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Stephen A Varvel, Ph.D.

  Pearsanta, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen A Varvel, Ph.D.

CONTACT

18048364439; svarvel@pearsanta.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)