Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT01652456
Status:
WITHDRAWN
Last Update Posted:
2018-01-24
First Post:
2012-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2012-07-26', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'systematic addiction consultation', 'timeFrame': '12 months after diagnosis', 'description': 'difference between abstinence in group A and abstinence in group B'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '24 months after diagnosis', 'description': 'median time between date of inclusion and date of first progression'}, {'measure': 'overall survival', 'timeFrame': '24 months after survival', 'description': 'median time between date of inclusion and date of death'}, {'measure': 'alcohol and tobacco consumption', 'timeFrame': 'baseline, 3 months, 6 months and 12 months after diagnosis', 'description': 'frequency of tobacco and alcohol consumption questionnaire : Fagerström, Alcohol Use Disorders Identification Test (AUDIT), Cut Down Annoyed Guilty Eye-Opener (CAGE-DETA), Cannabis abuse screening test (CAST), M.I.N.I.'}, {'measure': 'alcohol + tobacco withdrawal and addiction support', 'timeFrame': '12 months after diagnosis', 'description': 'difference between abstinence of group A and abstinence group B'}, {'measure': 'addiction follow up', 'timeFrame': '24 months after diagnosis', 'description': 'percentage of patient with a first addiction consultation, and willing to have a long term follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['addiction support', 'addiction specialist', 'lung cancer', 'head and neck cancer'], 'conditions': ['Head and Neck Cancer', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, interventional, randomized study for preventive and therapeutic strategies for patients with head and neck or Lung cancer; contribution of an addiction support'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first head and neck or lung cancer\n* first support\n* 18 ≤ age ≤ 60\n* lives in Lille Metropolis\n* having an addiction to alcohol and tobacco\n* covered by health insurance\n* signed informed consent\n\nExclusion Criteria:\n\n* prior cancer\n* mesothelioma and oesophageal cancer\n* unable to undergo trail medical follow up (geographical, social and psychological reasons)\n* pregnant or nursing woman\n* patient under guardianship'}, 'identificationModule': {'nctId': 'NCT01652456', 'briefTitle': 'Alcohol and Tobacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Alcohol and TObacco Consumption in Patients With Head and Neck Cancer : Interest of an Addiction Support', 'orgStudyIdInfo': {'id': 'ALTAKRA - 1205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Other: Addiction support']}, {'type': 'NO_INTERVENTION', 'label': 'Group B'}], 'interventions': [{'name': 'Addiction support', 'type': 'OTHER', 'description': 'one consultation with an addiction specialist', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59 020', 'city': 'Lille', 'country': 'France', 'facility': 'Oscar Lambret Center', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59 037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional et Universitaire - Hopital CALMETTE', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59 037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional et Universitaire - Hopital HURIEZ', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Corinne VANNIMENUS, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Régional et Universitaire'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}