Clinical trial NCT05245695: Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Official title: Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Keywords: Endometriosis
Biomarkers
Deep neural network
Lead sponsor: Aspira Women's Health
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women scheduled for a gynecologic surgery

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

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.

Eligibility 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 for symptomology consistent with possible endometriosis

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 24 months
Secondary outcomes:
measure: Performance
timeFrame: 24 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: New Horizons Clinical Trials
state: Arizona
city: Mesa
country: United States
facility: Arizona Gynecology Consultants
state: Arizona
city: Newark
country: United States
facility: Reproductive Associates of Delaware (RAD)
state: Delaware
city: Columbus
country: United States
facility: Midtown OBGYN North
state: Georgia
city: Stockbridge
country: United States
facility: Advanced Women's Care Center
state: Georgia
city: Newburgh
country: United States
facility: Cindy Basinski, MD
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Valley Stream
country: United States
facility: Nezhat Surgery for Gynecology/Oncology
state: New York
city: Cincinnati
country: United States
facility: Axia Women's Health
state: Ohio
city: Lancaster
country: United States
facility: May Grant
state: Pennsylvania
city: Lynchburg
country: United States
facility: Womens Health Services of Central Virginia
state: Virginia
Study officials:
affiliation: Aspira Women's Health
name: Todd Pappas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wykes CB, Clark TJ, Khan KS. Accuracy of laparoscopy in the diagnosis of endometriosis: a systematic quantitative review. BJOG. 2004 Nov;111(11):1204-12. doi: 10.1111/j.1471-0528.2004.00433.x. No abstract available.
citation: Gupta D, Hull ML, Fraser I, Miller L, Bossuyt PM, Johnson N, Nisenblat V. Endometrial biomarkers for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Apr 20;4(4):CD012165. doi: 10.1002/14651858.CD012165.
citation: Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21. doi: 10.1016/s0015-0282(97)81391-x. No abstract available.