Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-06 @ 11:55 AM
Study NCT ID:
NCT02705833
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2016-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 591}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2016-02-25', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Best Therapy Response defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) based on physician's assessment for each therapy regimen", 'timeFrame': 'approximately 12 months'}, {'measure': 'Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN', 'timeFrame': 'approximately 12 months'}, {'measure': 'Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN', 'timeFrame': 'approximately 12 months'}, {'measure': 'Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN', 'timeFrame': 'approximately 12 months'}, {'measure': 'Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN', 'timeFrame': 'approximately 12 months'}], 'secondaryOutcomes': [{'measure': 'Frequency of R/M SCCHN-related health care resource use', 'timeFrame': 'approximately 12 months'}, {'measure': 'Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics', 'timeFrame': 'approximately 12 months'}, {'measure': 'Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics', 'timeFrame': 'approximately 12 months'}]}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to characterize the medical management of squamous cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease (between 01July2013 and 30 June 2014) in the real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with R/M SCCHN between 01July2013 and 30June2014', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (18 years old or older) with a confirmed diagnosis or R/M head and neck, may be living or deceased at time of enrollment in the study\n* Diagnosis of R/M head and neck cancer between 01July2013 and 30June2014 (study index period)\n\nExclusion Criteria:\n\n* If female patient, pregnant or lactating between 01July2013 and 30June2014\n* Enrolled in cancer treatment-clinical trials since diagnosis of R/M head and neck cancer during the study index period'}, 'identificationModule': {'nctId': 'NCT02705833', 'briefTitle': 'Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada', 'orgStudyIdInfo': {'id': 'CA209-551'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population with R/M SCCHN', 'description': 'Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) patients diagnosed between 01July2013 and 30June2014, alive or deceased, at the time of data collection'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}