- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05698212
Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
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 Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Janan Van Osdell, MHSA
- Phone Number: 102 855-826-6638
- Email: janan@tammnet.com
Study Contact Backup
- Name: Somer Baburek, MBA
- Phone Number: 210-683-1069
- Email: somer@herabiotech.com
Study Locations
-
-
Michigan
-
Saginaw, Michigan, United States, 48602
- Not yet recruiting
- Valley Ob-Gyn Clinic, PC
-
Contact:
- Mackenzie Rittenberg
- Phone Number: 989-753-8453
- Email: mackenzie.rittenberg@elligodirect.com
-
Contact:
- Jackie Lang
- Phone Number: 989-753-8453
- Email: jacqueline.lang@elligodirect.com
-
Principal Investigator:
- Jacqueline A Robinsons, MD
-
-
Texas
-
Corpus Christi, Texas, United States, 78412
- Recruiting
- Corpus Christi Women's Center
-
Contact:
- Jessica Sanchez
- Phone Number: 361-851-5000
- Email: Jessica.sanchez@elligodirect.com
-
Contact:
- Monica Marroquin
- Phone Number: 361-851-5000
- Email: monica.marroquin@elligodirect.com
-
Principal Investigator:
- Charles R Kirkham, MD
-
Houston, Texas, United States, 77024
- Recruiting
- University of Texas Physician's Women's Center--Memorial City
-
Contact:
- Lori L Wink, MSN, NP
- Phone Number: 706-251-8339
- Email: lori.L.wink@uth.tmc.edu
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Principal Investigator:
- Sandry Hurtago, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HER001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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