MetriDx uterine biopsy test to find endometriosis biomarkers

Proof-of-Concept, Obs Study to Evaluate Accuracy of MetriDx Lab Developed Test (LDT) to Accurately Identify Endometriosis-specific Biological Markers Using Micro-fluidic Analysis of Cells Enabling Clinicians to Diagnose Endometriosis

This test tries to see if a simple uterine biopsy sent to a lab and analyzed by MetriDx's AI can detect endometriosis in people who are having or recently had laparoscopy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Hera Biotech, Inc. (Industry-sponsored)
• Locations: 3 sites (Saginaw, Michigan and 2 other locations)
• Trial ID: NCT05698212 on ClinicalTrials.gov

What this trial studies

Participants make two visits and have a brief office uterine biopsy (similar to a Pap smear) before they undergo laparoscopy as part of their clinical care. The biopsy sample is sent to a specialized lab where a proprietary microfluidic and AI-based MetriDx analysis examines cellular biomarkers, including connexins. Results from the MetriDx biopsy are compared to laparoscopy findings to measure diagnostic accuracy. The study enrolls an active group with suspected or known endometriosis and a control group without endometriosis who are having laparoscopy for other reasons.

Who should consider this trial

Good fit: People born female, ages 18–50, not pregnant, and either scheduled for laparoscopy for suspected or known endometriosis or undergoing laparoscopy for other reasons are ideal candidates.

Not a fit: Those who are pregnant, outside the 18–50 age range, have had endometriosis excision/ablation or GnRH treatment within the past 12 months, or who will not undergo laparoscopy are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could offer a less invasive way to diagnose endometriosis using an office uterine biopsy instead of laparoscopy.

How similar studies have performed: Using endometrial samples and molecular biomarkers to detect endometriosis is a relatively new approach with some encouraging preliminary data, but robust validation against laparoscopy is still limited.

Eligibility criteria

Inclusion Criteria:

* Able to understand and provide informed consent.
* Natural born female of childbearing potential.
* Age between 18 and 50, inclusive.
* Not pregnant at Visit 0 (screening) or Visit 1 (day of procedure).
* Free of systemic or pelvic disorder that, in the opinion of the investigator, may interfere with the tissue collection procedure, analysis of the tissue or increase the risk to subject.
* Must not have received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
* For Cohort 1 and 2:

  * Suspected of having endometriosis, or previously diagnosed with endometriosis, and currently recommended for laparoscopic surgery by physician.
  * Must have laparoscopic surgery within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day), or a laparoscopy on record within the 12 months prior to Visit 0 for diagnosis only.
  * Surgical report from prior laparoscopy must indicate that endometriosis was not treated with surgical ablation or excision.
  * Subjects will be assigned to Cohort 1 or 2 based on diagnosis and staging results from laparoscopy.
* Or for Cohort 3:

  * Not suspected of having endometriosis
  * no previous diagnosis or symptoms of endometriosis, who have had a laparoscopy for another reason, such as tubal ligation or other abdominal procedure, within the past 12 months prior to screening Visit 0,
  * or laparoscopy to be completed within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day).
  * Surgeon's report must have no supplemental observations of endometriosis lesions or diagnosis. Subjects will be assigned to Cohort 3.

Exclusion Criteria:

* Younger than 18 or 51 years or older.
* Surgical history of hysterectomy.
* Has received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.
* Cohort 3: Prior diagnosis of endometriosis, or surgical note from prior laparoscopy that indicates endometriosis lesions were observed.
* Has a BMI 40 or above.
* Is currently taking a blood thinner medication.
* Currently, pregnant, breast feeding, or has given birth in the last 6 months.
* Diagnosed with HIV, AIDS, hepatitis A, B, or C, or has active malignancy.
* Has a complicating condition that would pose a hazard to tissue handling.
* Undergoing fertility or hormone therapy treatments.
* History or evidence of uterine fibroids.
* History of reproductive cancer.
* Has a condition that, in the opinion of the investigator, would confound tissue collection or analysis.
* Has an active pelvic infection or other infections contra-indicated for laparoscopy.
* Has participated in any interventional clinical trial in the previous 90 days in which an investigational drug was administered.
* Has a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years.

Where this trial is running

Saginaw, Michigan and 2 other locations

• Valley OB-GYN Clinic, PC — Saginaw, Michigan, United States (Not_yet_recruiting)
• Corpus Christi Women's Center — Corpus Christi, Texas, United States (Recruiting)
• University of Texas Physician's Women's Center--Memorial City — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Sandra M Hurtado, MD — University of Texas Physicians Women's Center
• Study coordinator: Janan Van Osdell, MHSA

Conditions Endometriosis; Diagnosis; endometriosis; MetriDx; connexins; biological markers; micro-fluidic analysis; uterine tissue biopsy