Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-02 @ 6:41 AM
Study NCT ID:
NCT01719068
Status:
UNKNOWN
Last Update Posted:
2012-11-01
First Post:
2012-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-30', 'studyFirstSubmitDate': '2012-10-30', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of Model to Predict Workers at highest risk of lung cancer/mesothelioma', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mesothelioma', 'Lung Cancer', 'Early Detection'], 'conditions': ['Mesothelioma', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a pilot study that aims to develop a lung cancer screening program for workers in British Columbia, Canada exposed to asbestos who are at risk of developing lung cancer/pleural mesothelioma. This is high risk population is at of respiratory system diseases as a result of their occupational exposures. Additionally, knowledge garnered from this study will allow us to develop other studies that will further our understanding of asbestos related lung cancer and mesothelioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Workers in British Columbia who have been exposed to asbestos.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women or men age 50 to 79 years\n* history of exposure to asbestos at work and one or more of the following:\n\n * lung cancer risk ≥2% over 3 years or\n * asbestosis or pleural plaques on a chest x-ray or\n * abnormal auto-antibodies level using the EarlyCDT test\n* Capable of providing informed consent for screening procedures (low dose spiral CT, lung function, blood biomarkers).\n\nExclusion Criteria:\n\n* Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, or any disorder, that in the opinion of the physician unlikely to benefit from screening due to shortened life-expectancy from co-existing illnesses\n* Have been previously diagnosed with mesothelioma\n* Have had other cancer within the past 5 years with the exception of the following cancers: non-melanomatous skin cancer,localized prostate cancer, carcinoma in situ (CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must have ended \\>6 months before registration into this study\n* Pregnancy\n* Unwilling to have a low dose CT scan of chest\n* Unwilling to sign a consent'}, 'identificationModule': {'nctId': 'NCT01719068', 'briefTitle': 'Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'Early Detection of Lung Cancer and Mesothelioma in Workers Exposed to Asbestos', 'orgStudyIdInfo': {'id': 'H12-01812'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Workers exposed to asbestos'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z1L3', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sharon Gee', 'role': 'CONTACT', 'email': 'sgee@bccancer.bc.ca', 'phone': '604-675-8089'}, {'name': 'Stephen Lam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Annette McWilliams, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tawimas Shaipanich, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'British Columbia Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Sharon Gee', 'role': 'CONTACT', 'email': 'sgee@bccancer.bc.ca', 'phone': '604-675-8089'}], 'overallOfficials': [{'name': 'Stephen Lam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Columbia Cancer Agency'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'collaborators': [{'name': 'BC Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}