Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT01799395
Status:
TERMINATED
Last Update Posted:
2017-09-12
First Post:
2013-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Staff constraints made it impossibile to enroll consecutive patients, making the sample not representative of the true cancer population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2013-02-23', 'studyFirstSubmitQcDate': '2013-02-23', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of central airway obstruction', 'timeFrame': '12 months', 'description': 'The incidence will be measured over a 12 month period after diagnosis (or over the life span from diagnosis to death in patients who die before 1 year from the diagnosis)'}], 'secondaryOutcomes': [{'measure': 'Predictor variables associated with the presence/occurrence of central airway obstruction', 'timeFrame': '12 months'}, {'measure': 'Prevalence of central airway obstruction', 'timeFrame': '1 day', 'description': 'The prevalence of central airway obstruction will be evaluated at the time of diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).\n\nThe aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the predictors of central airway obstruction associated with advanced lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced lung cancer undergoing treatment and follow-up at the Oncology Units of the Azienda USL di Bologna (government structure that manages several public hospitals that "cover" a 800.000 inhabitants area)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation therapy\n\nExclusion Criteria:\n\n* Age \\< 18 year\n* Pregnancy\n* Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT01799395', 'briefTitle': 'Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Maggiore Bellaria Hospital, Bologna'}, 'officialTitle': 'Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer', 'orgStudyIdInfo': {'id': '13002-Trisolini'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lung Cancer', 'description': 'All patients with advanced lung cancer candidate for chemotherapy or chemotherapy + radiation therapy will be enrolled and followed-up for 1 year clinically and radiologically (Chest CT) to verify whether or not central airway obstruction is present at the time of diagnosis or occurs in the year following diagnosis (or in the life span from diagnosis and death in patients who die before 1 year of diagnosis). Furthermore, predictor variables possibly associated with central airway obstruction will be studied.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40010', 'city': 'Bentivoglio', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Bentivoglio Hospital', 'geoPoint': {'lat': 44.6369, 'lon': 11.41737}}, {'zip': '40100', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Bellaria Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '4013', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Maggiore Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '40054', 'city': 'Budrio', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Budrio Hospital', 'geoPoint': {'lat': 44.53745, 'lon': 11.53439}}, {'zip': '40017', 'city': 'San Giovanni in Persiceto', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'SS Salvatore Hospital', 'geoPoint': {'lat': 44.63838, 'lon': 11.18419}}], 'overallOfficials': [{'name': 'Rocco Trisolini, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maggiore Bellaria Hospital, Bologna, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maggiore Bellaria Hospital, Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Rocco Trisolini', 'investigatorAffiliation': 'Maggiore Bellaria Hospital, Bologna'}}}}