Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-05 @ 5:21 AM
Study NCT ID:
NCT05780957
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2023-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Cancer Early Detection (MCED) of Firefighters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Sensitivity, specificity, positive and negative predictive performance values (PPV and NPV) to detect cancer using Elypta's MCED test, as measured in plasma, in urine, and in plasma and urine combined", 'timeFrame': 'Up to 7 years'}, {'measure': "Sensitivity, specificity, positive and negative predictive performance values to detect cancer using Proteotype's MCED test, as measured in plasma.", 'timeFrame': 'Up to 2030'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Multi-Cancer Early Detection', 'MCED'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This study is an an observational prospective cohort research study to explore the performance of new blood and urine tests for the early detection of cancer among firefighters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Actively working firefighters of any adult age, any gender and any demographic group are eligible, as well as no limitations regarding general health status other than those specified in the protocol Eligibility Criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* Currently employed as a firefighter, full-time or part-time\n* Taking part in Vincere's First Responder Cancer Screening Program\n* Able to donate blood and urine sample\n* Able to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Deemed medically unfit for sample donation\n* Personal history of cancer in the last 5 years (with the exception of non-melanoma skin cancer)"}, 'identificationModule': {'nctId': 'NCT05780957', 'briefTitle': 'Multi-Cancer Early Detection (MCED) of Firefighters', 'organization': {'class': 'OTHER', 'fullName': 'Vincere Cancer Center'}, 'officialTitle': 'Multi-Cancer Early Detection (MCED) of Firefighters', 'orgStudyIdInfo': {'id': 'VCC-MCEDFF-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Firefighters who receive multi-cancer early detection (MCED) test', 'interventionNames': ['Other: MCED']}], 'interventions': [{'name': 'MCED', 'type': 'OTHER', 'description': 'multi-cancer early detection (MCED) test', 'armGroupLabels': ['Firefighters who receive multi-cancer early detection (MCED) test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Lau, MD', 'role': 'CONTACT', 'email': 'drlau@vincerecancer.com', 'phone': '(480)306-5390'}, {'name': 'Vershalee Shukla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vincere Cancer Center', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'centralContacts': [{'name': 'Christine Lau, MD', 'role': 'CONTACT', 'email': 'drlau@vincerecancer.com', 'phone': '480-306-5390'}], 'overallOfficials': [{'name': 'Vershalee Shukla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vincere Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vincere Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elypta', 'class': 'INDUSTRY'}, {'name': 'Proteotype', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}