Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04487405
Status:
TERMINATED
Last Update Posted:
2023-12-26
First Post:
2020-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 721}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'cohort C looked at feasibility of genetics \\& protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OVAnex', 'timeFrame': '12 months', 'description': 'OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adnexal Mass']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2 and other germline DNA variants.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.\n* Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.\n\nExclusion Criteria:\n\n* Patient is less than 18 years of age\n* Patient is not being treated in the U.S.'}, 'identificationModule': {'nctId': 'NCT04487405', 'acronym': 'OVAnex', 'briefTitle': 'A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants', 'organization': {'class': 'INDUSTRY', 'fullName': "Aspira Women's Health"}, 'officialTitle': 'A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants', 'orgStudyIdInfo': {'id': '04-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Symptomatic with adnexal mass', 'interventionNames': ['Device: OVAnex']}, {'label': 'Group B', 'description': 'Asymptomatic with adnexal mass', 'interventionNames': ['Device: OVAnex']}, {'label': 'Group C', 'description': 'Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant', 'interventionNames': ['Device: OVAnex']}], 'interventions': [{'name': 'OVAnex', 'type': 'DEVICE', 'description': 'OVAnex is a multivarite index assay assessing ovarian cancer risk', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': "Women's Health Arizona", 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Altus Research', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '31901', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'MidTown OBGYN', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Premier OBGYN of Minnesota', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Square Care Health', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '45211', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Seven Hills Clinical Research Group', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '17601', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'May Grant OB/GYN', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '78748', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Hill Country OBGYN Associates', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], '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'}}}}