Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis (NCT06907550)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Pearsanta, Inc. — Richmond, Virginia
🧪 Interventions in This Study
- The Mitomic Endometriosis Test (MET) blood test for early detection of endometriosis (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Pearsanta, Inc. — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (804) 836-4439
Email: svarvel@pearsanta.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Endometriosis
- Nutritional Intervention for Endometriosis — Washington D.C., District of Columbia
- Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI — Chapel Hill, North Carolina
- Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain — Anniston, Alabama
- The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA — Palo Alto, California
- Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance — New Haven, Connecticut
- Endometriosis and Health Care System Utilization in British Columbia — Vancouver, British Columbia
Explore by condition: All Endometriosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.