Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 2:23 AM
Study NCT ID:
NCT04627350
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071837', 'term': 'Fibrillins'}], 'ancestors': [{'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-07', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-11-07', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of secondary examinations', 'timeFrame': '2023', 'description': 'The number, cost, and complications of secondary examinations generated by screening LDCT.'}, {'measure': 'Number of secondary findings', 'timeFrame': '2023', 'description': 'The number and types of secondary findings and their clinical relevance (potentially important vs. unimportant findings) will be reported.'}], 'primaryOutcomes': [{'measure': 'The number of cancers detected at stage I', 'timeFrame': '2023', 'description': 'The proportion of cancers diagnosed at a resectable stage (stage I) vs. non-resectable stage (II-IV) will be compared to the stage distribution in an unscreened population'}], 'secondaryOutcomes': [{'measure': 'The cost per diagnosis at a resectable stage', 'timeFrame': '2023', 'description': 'The cost per diagnosis at a resectable stage will encompass the cost of low-dose CT (LDCT), follow-up LDCT, verification (PET/CT, tissue sampling, bronchoscopy).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'low dose CT'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate and optimize entry criteria for the proposed programme for early detection of lung cancer in the Czech Republic.\n\nAn estimated 3200 high-risk (age 55-74 years, \\>30 pack-years) asymptomatic individuals will undergo baseline low-dose chest CT (LDCT) and a follow-up LDCT at 1 year. Patients with poor performance status (PS) 2-4, history of malignancy in the past 10 years, chest CT in the past 1 year, bodyweight \\>140kg will not be included.\n\nThe patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, CT imaging of the thorax, and will undergo spirometry.\n\nOutcomes of the study include:\n\n* optimization of entry criteria, optimization of timing of a follow-up LDCT and management of the patients, proposal of quality assurance indicators\n* influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost\n* cost-effectiveness of the screening program\n* evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Defined by eligibility criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55-74 years\n* Smoking: \\>= 30 pack-years, smoker or ex-smoker \\<15 years\n* Performance status (0-1) - can climb at least one floor without any difficulty or pause\n\nExclusion Criteria:\n\n* Body weight above 140 kg\n* Malignant disease within the last 10 years (except non-melanoma skin cancer).\n* Chest CT less than one year ago\n* Clinical signs suspicious of lung cancer (weight loss, new cough, hemoptysis)'}, 'identificationModule': {'nctId': 'NCT04627350', 'acronym': 'ELEGANCE', 'briefTitle': 'Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals', 'orgStudyIdInfo': {'id': 'R01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LDCT', 'description': 'Single arm - all patients undergo low-dose CT (LDCT) examination of lungs', 'interventionNames': ['Other: Response to pulmonary finding (nodule, mass)']}], 'interventions': [{'name': 'Response to pulmonary finding (nodule, mass)', 'type': 'OTHER', 'description': 'Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax', 'armGroupLabels': ['LDCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12808', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Lukas Lambert', 'role': 'CONTACT', 'email': 'lambert.lukas@gmail.com', 'phone': '+420 224962232'}], 'facility': 'General University Hospital in Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Lukas Lambert, M.D.', 'role': 'CONTACT', 'email': 'lambert.lukas@gmail.com', 'phone': '+420224962232'}], 'overallOfficials': [{'name': 'Lukas Lambert, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General University Hospital, Prague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'General University Hospital, Prague', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Lukas Lambert', 'investigatorAffiliation': 'General University Hospital, Prague'}}}}