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Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

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ClinicalTrials.gov Identifier: NCT05245695
Recruitment Status : Recruiting
First Posted : February 18, 2022
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Aspira Women's Health

Study Description
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Brief Summary:
The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test

Condition or disease Intervention/treatment
Endometriosis Other: Observational study, no intervention

Detailed Description:

The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain.

The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Actual Study Start Date : July 12, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Observational study, no intervention
    Observational study, no intervention

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: 24 months ]
    The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively


Secondary Outcome Measures :
  1. Performance [ Time Frame: 24 months ]
    Examining the performance of the test in patients stratified by pain severity and other clinical factors.


Biospecimen Retention:   Samples With DNA
Serum Cell-free DNA

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women scheduled for a gynecologic surgery
Criteria

Inclusion Criteria:

  • Participant is willing and able to provide written informed consent.
  • Participant is a female aged 14 to 50 years old at time of consent.
  • Participant is scheduled to undergo laparotomy or laparoscopy secondary to chronic pain associated with suspected endometriosis.

Exclusion Criteria:

  • Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
  • Participant is a female in a pre-menarchal state.
  • Participant is pregnant.
  • Participant has an active malignancy.
  • Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
  • Participant has an active pelvic infection or other infections contraindicated for surgery.
  • Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered.
  • Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
  • Participant is under 14 years old or over 50 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05245695


Contacts
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Contact: Silvana Franco 2033470151 sfranco@aspirawh.com
Contact: Kayla Nolan knolan@aspirawh.com

Locations
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United States, Arizona
New Horizons Clinical Trials Recruiting
Chandler, Arizona, United States, 852224
Contact: Saira Flores, MD         
Contact    (480) 496-2236      
Principal Investigator: Monte Swarup         
Arizona Gynecology Consultants Recruiting
Mesa, Arizona, United States, 85203
Contact: Kristina Calligan       kcalligan@azgyn.com   
Principal Investigator: Kelly Roy, MD         
United States, Delaware
Reproductive Associates of Delaware (RAD) Recruiting
Newark, Delaware, United States, 19713
Contact: Eileen Davies         
Principal Investigator: Ronald Feinberg         
United States, Georgia
Midtown OBGYN North Recruiting
Columbus, Georgia, United States, 31909
Contact: Rebecca Watkins       rebeccaw@midtownob.com   
Principal Investigator: Serena Tidwell         
United States, Indiana
Axia Recruiting
Greenwood, Indiana, United States, 46143
Contact: Amanda Schulz       amanda.schulz@axiawh.com   
Principal Investigator: Gerard Reilly, MD         
United States, New York
Nezhat Surgery for Gynecology/Oncology Recruiting
Valley Stream, New York, United States, 11581
Contact: Esra Demirel       esra@farrnezhatmd.com   
Principal Investigator: Farr Nezhat, MD         
United States, Ohio
Axia Women's Health Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Brigette Tillman         
Principal Investigator: Gerard Reilly         
United States, Pennsylvania
May Grant Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Jillian Justice         
Principal Investigator: Kent Meldrum         
United States, Virginia
Womens Health Services of Central Virginia Recruiting
Lynchburg, Virginia, United States, 24502
Contact: Whittney Critchley    434-485-7059      
Principal Investigator: Wade Neiman         
Sponsors and Collaborators
Aspira Women's Health
Investigators
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Principal Investigator: Todd Pappas, PhD Aspira Women's Health
More Information
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Publications:

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Responsible Party: Aspira Women's Health
ClinicalTrials.gov Identifier: NCT05245695    
Other Study ID Numbers: 12-2021
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aspira Women's Health:
Endometriosis
Biomarkers
Deep neural network
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Diseases
Pain
Neurologic Manifestations