Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers

January 24, 2023 updated by: Hera Biotech, Inc.

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 study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery. The tissue is sent to lab for cellular analysis with a proprietary AI (artificial intelligence) technology.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

This study involves 2 visits to the site and possibly as outpatient surgical center, and the participant will be involved in the for as little as 1 day to as much as 60 days, mainly depending on scheduling of laparoscopy. Eligible participants in the active group will have history of endometriosis and will be having a laparoscopy for diagnosis within the next few weeks. Eligible participants in the control group will have no history of endometriosis but will need or have recently had a laparoscopy surgical procedure for a reasons such as tubal ligation.

The participant will have an uterine biopsy (similar to a pap smear) in the physician's office before the laparoscopy. The biopsied tissue will be sent to a special lab for analysis and diagnosis of endometriosis by an innovative proprietary procedure that analyses the cells of the tissue collected in the biopsy.

The results of the biopsy will be compared to the laparoscopy for accuracy.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Janan Van Osdell, MHSA
  • Phone Number: 102 855-826-6638
  • Email: janan@tammnet.com

Study Contact Backup

Study Locations

    • Michigan
    • Texas
      • Corpus Christi, Texas, United States, 78412
      • Houston, Texas, United States, 77024
        • Recruiting
        • University of Texas Physician's Women's Center--Memorial City
        • Contact:
        • Principal Investigator:
          • Sandry Hurtago, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cohort 1
Endometriosis diagnosed at stage 1 or 2
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
Active Comparator: Cohort 2
Endometriosis diagnosed at stage 3 or 4
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
Other: Cohort 3

Control--Not suspected of having and absence of endometriosis confirmed by diagnostic test.

This group has uterine tissue biopsy and laparoscopy for non-endometriosis indication, i.e. tubal ligation

Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 1 week after laparoscopy
Endometriosis diagnosis
1 week after laparoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 1 week after laparoscopy
Accurate staging of endometriosis
1 week after laparoscopy
Tertiary Outcome
Time Frame: 1 week after providing menstrual effluent sample
observe and explore any relationship between subject's estrogen and progesterone levels and MetriDx results.
1 week after providing menstrual effluent sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sandra M Hurtado, MD, University of Texas Physicians Women's Center
  • Principal Investigator: Charles R Kirkham, MD, Corpus Christi Women's Clinic
  • Principal Investigator: Jacqueline A Robinson, MD, Valley OB-GYN Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Anticipated)

March 25, 2023

Study Completion (Anticipated)

April 10, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HER001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

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