Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-18 @ 4:06 PM
Study NCT ID:
NCT06804395
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2034-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Pathogenic Germline Variants (PGV)', 'timeFrame': '10 years from study initiation as defined based on the date the first patient was enrolled.', 'description': 'Compare the number of detected PGVs as measured by a universal multi-gene panel, proactively, in a diverse community-based population of individuals. PGV rate will be compared to NCCN genetic testing criteria at baseline, and to longitudinal cancer outcomes.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Cancer', 'timeFrame': '10 years from study enrollment.', 'description': 'The number of new cancer cases diagnosed in participants with specific PGV\'s (i.e. "at high risk" to develop cancer) compared to those without these markers (i.e. "low / average risk") over a period of ten years as described below.'}, {'measure': 'Genetic Risk Score (GRS)', 'timeFrame': '10 years from study enrollment', 'description': "GRS is a score that includes demographic data, Family history, Medical history, Epidemiologic risk factors and data stemming from SOC biospecimens analysis. The purpose of this is to assess the association between PGV's, GRS's and the time to cancer diagnosis."}, {'measure': 'Environmental and Lifestyle Factors', 'timeFrame': '10 years from study enrollment', 'description': 'We will evaluate the interaction between genetic markers and environmental/lifestyle factors (e.g., smoking, diet, physical activity) on cancer risk. This will be achieved by assessing environmental/lifestyle factors via questionnaires and correlating these with cancer incidence (Secondary Outcome 2)'}, {'measure': 'Impact of Early Detection and Prevention on Cancer Outcomes', 'timeFrame': '10 years from study enrollment', 'description': 'This study will evaluate the association between various preventive measures (e.g., regular screenings, lifestyle modifications) as reported via questionnaires and cancer outcomes (defined as overall survival, and disease-free survival).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Prevention', 'Cancer Risk', 'Cancer Early Detection', 'Cancer High Risk'], 'conditions': ['Cancer Risk']}, 'descriptionModule': {'briefSummary': 'Early diagnosis of cancer allows for better treatment outcomes, higher survival rates, and lower costs of care. It is shown that cancer monitoring for cancer in at-risk populations is a key component in early diagnosis. The HMH Hennessey Institute for Cancer prevention and Applied Molecular Science (HICAP) is a newly founded institute, providing clinical services for cancer screening and risk assessment to the community, as well as research in cancer risk and prevention. The CanScan registry will prospectively collect data from participants in the form of questionnaires. The registry will also capture data that is collected as per non-research assessments, for participants who consent to participate. The registry will facilitate better understanding of cancer risk, screening, and diagnostics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who are at risk for cancer or who have taken the Hennessy Institute cancer risk assessment (I.e participated in their cancer prevention program)', 'healthyVolunteers': True, 'eligibilityCriteria': '* Adults ( 18 and older)\n* Ability to provide own consent\n* Must meet at least one of the below criteria, Indicating an increased risk for cancer, any of the following:\n\n * Family or personal history suggests a familial/hereditary disorder known or suspected of predisposition to cancer.\n * Personal factors associated with an increased risk for cancer include benign breast disease, polyps, tobacco use, etc.as defined by the investigator.\n * Family members of participating individuals.\n* Any participant in the HICAP program regardless of cancer risk'}, 'identificationModule': {'nctId': 'NCT06804395', 'briefTitle': 'CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management', 'orgStudyIdInfo': {'id': 'Pro2024-0211'}}, 'contactsLocationsModule': {'locations': [{'zip': '07462', 'city': 'Totowa', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lee Ifhar, MSs, CCRP', 'role': 'CONTACT', 'email': 'Lee.ifhar@hmhn.org', 'phone': '862-657-4227'}], 'facility': 'Hennessy Institute for Cancer Prevention and Applied Molecular Medicine', 'geoPoint': {'lat': 40.9051, 'lon': -74.20987}}], 'centralContacts': [{'name': 'Lee Ifhar, MSc, CCRP', 'role': 'CONTACT', 'email': 'Lee.ifhar@hmhn.org', 'phone': '862-657-4227'}, {'name': 'Renata Castro, MS', 'role': 'CONTACT', 'email': 'Renata.Castro@hmh.org'}], 'overallOfficials': [{'name': 'Elias Obeid, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}