Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-18 @ 1:58 AM
Study NCT ID:
NCT03687151
Status:
RECRUITING
Last Update Posted:
2018-09-27
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Population-based Cancer Observatory
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'}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "number of each cancer of the French Region Sud-Provence-Alpes-Côte d'Azur", 'timeFrame': '50 years', 'description': 'each cancer is definite by :number of Date of diagnosis, Tumor location, Histology, ADICAP codes, CIM-O codes, Age, Gender and Geolocation.\n\nnumber of classification of cancer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "Cancer is the leading cause of death in Western countries. In France cancer control plans (National screening programmes) and recommendations for the management of cancer patients (multidisciplinary team meetings), have been implemented. Evaluating the effectiveness of these policies aiming for improved prevention and management is essential. However to conduct such an evaluation, a baseline reference requiring ongoing, reliable and complete data collection is necessary and can be used for epidemiological research.\n\nThere is no cancer registry in the French Region Sud-Provence-Alpes-Côte d'Azur. In view of this situation, the regional Health Agency appointed the public health department of the Nice Côte d'Azur University and the Centre for computerized pathology data collection (CRISAP-PACA) to develop a Cancer Observatory. Since 2005, the public health department collects data concerning invasive and in situ cancers from all the histopathology labs in the French Region Sud-Provence-Alpes-Côte d'Azur, gathered in the CRISAP-PACA, and transmits incidence cancer rates to the regional Health Agency. In 2007, a quality control procedure, comparing a random sample of data collected by the Cancer Observatory with pathology lab reports, confirmed the validity of the collected data with fewer than 3% in disagreement with the report's conclusions. In 2008, the estimated completeness of cancer records collected from histopathology laboratories was higher than 90% for new cases of breast and colorectal cancer within the age range concerned by the screening programme. Since 2012, public and private hospitals treating cancer patients as well as the regional cancer network ONCOPACA, coordinating multiple team meetings, have been contacted to transmit to the public health department cases of cancer without histological diagnosis. In addition, patients with cancer have been geolocated to study the influence of environmental exposures on the occurrence of cancers (patients living near of waste incinerator, highways)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All subjects with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur.\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT03687151', 'acronym': 'cancer observ', 'briefTitle': 'Population-based Cancer Observatory', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': "Population-based Cancer Observatory of the French Region Sud-Provence-Alpes-Côte d'Azur Recruiting Incident Cases of Cancer Since 2005", 'orgStudyIdInfo': {'id': '18-DSP-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with a diagnosis of invasive or in situ cancer', 'description': "patients with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur since 2005", 'interventionNames': ['Other: non intervention / observationnal']}], 'interventions': [{'name': 'non intervention / observationnal', 'type': 'OTHER', 'description': 'non intervention / observationnal', 'armGroupLabels': ['patients with a diagnosis of invasive or in situ cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'eugenia MARINE BARJOAN, PH', 'role': 'CONTACT', 'email': 'marine-barjoan.e@chu-nice.fr', 'phone': '33492035635'}, {'name': 'laurent BAILLY, PH', 'role': 'CONTACT', 'email': 'bailly.l@chu-nice.fr', 'phone': '33492035635'}, {'name': 'eugenia MARINE BARJOAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'eugenia MARINE BARJOAN, PH', 'role': 'CONTACT', 'email': 'marine-barjoan.e@chu-nice.fr', 'phone': '33492035635'}, {'name': 'laurent BAILLY, PH', 'role': 'CONTACT', 'email': 'bailly.l@chu-nice.fr', 'phone': '33492035635'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}