NCT05245695

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2022Jun 2026

First Submitted

Initial submission to the registry

February 1, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

February 1, 2022

Last Update Submit

June 23, 2025

Conditions

Endometriosis

Keywords

EndometriosisBiomarkersDeep neural network

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity

    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

    24 months

Secondary Outcomes (1)

  • Performance

    24 months

Interventions

Observational study, no interventionOTHER

Observational study, no intervention

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Women scheduled for a gynecologic surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

New Horizons Clinical Trials

Chandler, Arizona, 852224, United States

RECRUITING

Velvet Clinical Research

Burbank, California, 91506, United States

RECRUITING

Reproductive Associates of Delaware (RAD)

Newark, Delaware, 19713, United States

RECRUITING

Midtown OBGYN North

Columbus, Georgia, 31909, United States

RECRUITING

Cindy Basinski, MD

Forest Hill, Indiana, 47630, United States

RECRUITING

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Nezhat Surgery for Gynecology/Oncology

Valley Stream, New York, 11581, United States

RECRUITING

Seven Hills Clinical Research

Cincinnati, Ohio, 45242, United States

RECRUITING

May Grant

Lancaster, Pennsylvania, 17601, United States

RECRUITING

Womens Health Services of Central Virginia

Lynchburg, Virginia, 24502, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15521864BACKGROUND

  • 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.

    PMID: 27094925BACKGROUND

  • 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.

    PMID: 9130884BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum Cell-free DNA

MeSH Terms

Conditions

Endometriosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Todd Pappas, PhD

    Aspira Women's Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marla Then, CRC

CONTACT

844-277-4721mthen@aspirawh.com

Silvana Franco

CONTACT

sfranco@aspirawh.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 18, 2022

Study Start

July 12, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(10)