Clinical trial NCT05698212: Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometriosis
Diagnosis
Keywords: endometriosis
MetriDx
connexins
biological markers
micro-fluidic analysis
uterine tissue biopsy
Lead sponsor: Hera Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two cohorts defined by confirmed diagnosis of endometriosis and further grouping by staging of endometriosis A third cohort of control participants who have not been suspected or diagnosed with endometriosis
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

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.

Primary outcomes:
measure: Primary Outcome
timeFrame: 1 week after laparoscopy
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 1 week after laparoscopy
measure: Tertiary Outcome
timeFrame: 1 week after providing menstrual effluent sample
Other outcomes:
Locations:
city: Saginaw
country: United States
facility: Valley OB-GYN Clinic, PC
state: Michigan
city: Corpus Christi
country: United States
facility: Corpus Christi Women's Center
state: Texas
city: Houston
country: United States
facility: University of Texas Physician's Women's Center--Memorial City
state: Texas
Study officials:
affiliation: University of Texas Physicians Women's Center
name: Sandra M Hurtado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corpus Christi Women's Clinic
name: Charles R Kirkham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Valley OB-GYN Clinic
name: Jacqueline A Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: