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

Primary Purpose

Endometriosis, Diagnosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MetriDx
Sponsored by
Hera Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometriosis focused on measuring endometriosis, MetriDx, connexins, biological markers, micro-fluidic analysis, uterine tissue biopsy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Valley OB-GYN Clinic, PC
  • Corpus Christi Women's CenterRecruiting
  • University of Texas Physician's Women's Center--Memorial CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Endometriosis diagnosed at stage 1 or 2

Endometriosis diagnosed at stage 3 or 4

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

Outcomes

Primary Outcome Measures

Primary Outcome
Endometriosis diagnosis

Secondary Outcome Measures

Secondary Outcome
Accurate staging of endometriosis
Tertiary Outcome
observe and explore any relationship between subject's estrogen and progesterone levels and MetriDx results.

Full Information

First Posted
November 29, 2022
Last Updated
January 24, 2023
Sponsor
Hera Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05698212
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
March 25, 2023 (Anticipated)
Study Completion Date
April 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hera Biotech, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Diagnosis
Keywords
endometriosis, MetriDx, connexins, biological markers, micro-fluidic analysis, uterine tissue biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Masking Description
The lab associates conducting the diagnosis tests are blinded.
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
Endometriosis diagnosed at stage 1 or 2
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
Endometriosis diagnosed at stage 3 or 4
Arm Title
Cohort 3
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
MetriDx
Intervention Description
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
Primary Outcome Measure Information:
Title
Primary Outcome
Description
Endometriosis diagnosis
Time Frame
1 week after laparoscopy
Secondary Outcome Measure Information:
Title
Secondary Outcome
Description
Accurate staging of endometriosis
Time Frame
1 week after laparoscopy
Title
Tertiary Outcome
Description
observe and explore any relationship between subject's estrogen and progesterone levels and MetriDx results.
Time Frame
1 week after providing menstrual effluent sample

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Natural born female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janan Van Osdell, MHSA
Phone
855-826-6638
Ext
102
Email
janan@tammnet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Somer Baburek, MBA
Phone
210-683-1069
Email
somer@herabiotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra M Hurtado, MD
Organizational Affiliation
University of Texas Physicians Women's Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles R Kirkham, MD
Organizational Affiliation
Corpus Christi Women's Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacqueline A Robinson, MD
Organizational Affiliation
Valley OB-GYN Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley OB-GYN Clinic, PC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mackenzie Rittenberg
Phone
989-753-8453
Email
mackenzie.rittenberg@elligodirect.com
First Name & Middle Initial & Last Name & Degree
Jackie Lang
Phone
989-753-8453
Email
jacqueline.lang@elligodirect.com
First Name & Middle Initial & Last Name & Degree
Jacqueline A Robinsons, MD
Facility Name
Corpus Christi Women's Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Sanchez
Phone
361-851-5000
Email
Jessica.sanchez@elligodirect.com
First Name & Middle Initial & Last Name & Degree
Monica Marroquin
Phone
361-851-5000
Email
monica.marroquin@elligodirect.com
First Name & Middle Initial & Last Name & Degree
Charles R Kirkham, MD
Facility Name
University of Texas Physician's Women's Center--Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori L Wink, MSN, NP
Phone
706-251-8339
Email
lori.L.wink@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sandry Hurtago, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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