Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
NCT ID: NCT05698212
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2022-09-14
2023-04-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Cohort 1
Endometriosis diagnosed at stage 1 or 2
MetriDx
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
Cohort 2
Endometriosis diagnosed at stage 3 or 4
MetriDx
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
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
MetriDx
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
Interventions
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MetriDx
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Hera Biotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sandra M Hurtado, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Physicians Women's Center
Charles R Kirkham, MD
Role: PRINCIPAL_INVESTIGATOR
Corpus Christi Women's Clinic
Jacqueline A Robinson, MD
Role: PRINCIPAL_INVESTIGATOR
Valley OB-GYN Clinic
Locations
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Valley OB-GYN Clinic, PC
Saginaw, Michigan, United States
Corpus Christi Women's Center
Corpus Christi, Texas, United States
University of Texas Physician's Women's Center--Memorial City
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HER001
Identifier Type: -
Identifier Source: org_study_id
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