Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Study Details
Study Description
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 | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- Sensitivity and Specificity [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
- Performance [24 months]
Examining the performance of the test in patients stratified by pain severity and other clinical factors.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant is willing and able to provide written informed consent.
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Participant is a female aged 14 or older at time of consent.
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Participant is scheduled to undergo laparotomy or laparoscopy secondary to chronic pain associated with suspected endometriosis.
Exclusion Criteria:
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Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
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Participant is a female in a pre-menarchal state.
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Participant is pregnant.
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Participant has an active malignancy.
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Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
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Participant has an active pelvic infection or other infections contraindicated for surgery.
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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.
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Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Horizons Clinical Trials | Chandler | Arizona | United States | 852224 |
| 2 | Seven Hills/ Axia Women's Health | Greenwood | Indiana | United States | 46143 |
| 3 | May Grant | Lancaster | Pennsylvania | United States | 17601 |
| 4 | Womens Health Services of Central Virginia | Lynchburg | Virginia | United States | 24502 |
Sponsors and Collaborators
- Aspira Women's Health
Investigators
- Principal Investigator: Lesley Northrop, PhD, FACMG, Aspira Women's Health
Study Documents (Full-Text)
None provided.More Information
Publications
- 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:CD012165. doi: 10.1002/14651858.CD012165. Review.
- Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21.
- 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. Review.
- 12-2021