Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
Study NCT ID:
NCT05245695
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2022-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum Cell-free DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': '24 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Performance', 'timeFrame': '24 months', 'description': 'Examining the performance of the test in patients stratified by pain severity and other clinical factors.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'Biomarkers', 'Deep neural network'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '15521864', 'type': 'BACKGROUND', '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.'}, {'pmid': '27094925', 'type': 'BACKGROUND', '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.'}, {'pmid': '9130884', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women scheduled for a gynecologic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to provide written informed consent.\n* Participant is a female aged 14 to 50 years old at time of consent.\n* Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis\n\nExclusion Criteria:\n\n* Participant is a female in a pre-menarchal state.\n* Participant is pregnant.\n* Participant has an active malignancy.\n* Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.\n* Participant has an active pelvic infection or other infections contraindicated for surgery.\n* 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.\n* Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.\n* Participant is under 14 years old or over 50 years old'}, 'identificationModule': {'nctId': 'NCT05245695', 'briefTitle': 'Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)', 'organization': {'class': 'INDUSTRY', 'fullName': "Aspira Women's Health"}, 'officialTitle': 'Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)', 'orgStudyIdInfo': {'id': '12-2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational study, no intervention', 'type': 'OTHER', 'description': 'Observational study, no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '852224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Saira Flores, MD', 'role': 'CONTACT', 'email': 'sflores@aoafamily.com'}, {'role': 'CONTACT', 'phone': '(480) 496-2236'}, {'name': 'Monte Swarup', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Horizons Clinical Trials', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '91506', 'city': 'Burbank', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica Torres', 'role': 'CONTACT', 'email': 'mtorres@velvetclinicalresearch.com', 'phone': '3235270907'}, {'name': 'Jose Medrano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Velvet Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eileen Davies', 'role': 'CONTACT', 'email': 'edavies@radfertility.com'}, {'name': 'Ronald Feinberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reproductive Associates of Delaware (RAD)', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '31909', 'city': 'Columbus', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Watkins', 'role': 'CONTACT', 'email': 'rebeccaw@midtownob.com'}, {'name': 'Serena Tidwell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Midtown OBGYN North', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '47630', 'city': 'Forest Hill', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alicia Sollman', 'role': 'CONTACT', 'email': 'alicia@drbasinski.com', 'phone': '812-853-3500'}, {'name': 'Cindy Basinski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cindy Basinski, MD', 'geoPoint': {'lat': 39.257, 'lon': -85.61331}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samya El Sayed, MD', 'role': 'CONTACT', 'email': 'selsaye4@jh.edu'}, {'name': 'James Segar, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '11581', 'city': 'Valley Stream', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Cote, MD', 'role': 'CONTACT', 'email': 'sharon@farrnezhatmd.com'}, {'name': 'Farr Nezhat, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nezhat Surgery for Gynecology/Oncology', 'geoPoint': {'lat': 40.66427, 'lon': -73.70846}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brigette Tillman', 'role': 'CONTACT', 'email': 'brigette.tillman@axiawh.com'}, {'name': 'Gerard Reilly', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seven Hills Clinical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '17601', 'city': 'Lancaster', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aelxa Trimble', 'role': 'CONTACT', 'email': 'alexamish5@gmail.com'}, {'name': 'Kent Meldrum', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'May Grant', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Whittney Calohan', 'role': 'CONTACT', 'email': 'wcalohan@whscv.com', 'phone': '434-485-7059'}, {'name': 'Wade Neiman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Womens Health Services of Central Virginia', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'centralContacts': [{'name': 'Marla Then, CRC', 'role': 'CONTACT', 'email': 'mthen@aspirawh.com', 'phone': '844-277-4721'}, {'name': 'Silvana Franco', 'role': 'CONTACT', 'email': 'sfranco@aspirawh.com'}], 'overallOfficials': [{'name': 'Todd Pappas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Aspira Women's Health"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Aspira Women's Health", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}