Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-01 @ 1:57 PM
Study NCT ID:
NCT06157957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Screening Smoking Cessation AND Respiratory Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D020340', 'term': 'Tobacco Use Cessation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of lung cancer in early stage in a high risk population during a lung cancer screening programme. We measure this outcome depending on the CT results.', 'timeFrame': '0 years until 5 years', 'description': 'Lung cancer screening'}, {'measure': 'The number of patients who quit smoking during a lung cancer screening program. We will measure this parameter by recording smoking cessation during the 5 years.', 'timeFrame': '0 years until 5 years', 'description': 'Tobacco Cessation'}, {'measure': 'The number of patients who present other diseases associated with smoking such as emphysema, COPD or coronary pathology. We will measure this parameter by means of spirometry and CT scan.', 'timeFrame': '0 years until 5 years', 'description': 'Respiratory assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'tobacco cessation', 'respiratory assessment'], 'conditions': ['Lung Cancer', 'Protection Against Malignant Lung Neoplasm (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The CASSANDRA project (Cancer Screening, Smoking Cessation, AND Respiratory Assessment) is a project led by SEPAR whose main coordinators are Dr. Luis Seijo, a pulmonologist at the Clínica Universitaria de Navarra, and Dr. Juan Carlos Trujillo-Reyes, a thoracic surgeon at the Hospital de la Santa Creu I Sant Pau and Coordinator of the Thoracic Oncology Area, in addition to the collaboration of a large number of professionals with expertise in lung cancer screening.\n\nDespite its proven efficacy, Spain does not yet have a unified lung cancer screening protocol. The aim of the CASSANDRA project is to initiate a national screening program that can join forces with existing smoking cessation programs in Spain, which have proven to be insufficient in reducing the number of people affected by lung cancer.\n\nCASSANDRA aims to analyze the feasibility of implementing a lung cancer screening program in Spain implemented in the public health system and carry out a cost-effectiveness analysis', 'detailedDescription': 'CASSANDRA aims to be the first lung cancer screening pilot project in Spain. A project to assess the feasibility of implementation as well as to look for models that allow a better selection of the cases to be screened.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-75 years active smoker with cumulative dose of \\>20 packets/year\n* Age 50-75 years ex-smoker less than 15 years old with cumulative dose of \\> 20 packets/year\n\nExclusion Criteria:\n\n* Pre-existing or new-onset comorbidities that, in the opinion of the coordinator, prevent surgical resection if lung cancer is found on low dose computed tomography (LDCT) scan, for example, severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume at one second (FEV1) \\< 30%.\n* Inability to sign the informed consent or collaborate with the CT scan.\n* Performing a chest CT for any reason in the previous year or planned CT for any reason in the next 3 months.\n* Subjects with a history of any cancer (except non-melanoma skin cancer) in the 5 years prior to inclusion in the screening program.'}, 'identificationModule': {'nctId': 'NCT06157957', 'acronym': 'CASSANDRA', 'briefTitle': 'Cancer Screening Smoking Cessation AND Respiratory Assessment', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Lung Cancer Screening Pilot Programme: Cancer Screening Smoking Cessation AND Respiratory Assessment', 'orgStudyIdInfo': {'id': 'Hospital de Sant Pau'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active smokers', 'description': 'We do a CT scan in active smokers and ex-smokers plus an spirometry combined to a tobacco cessation programme in active smokers', 'interventionNames': ['Diagnostic Test: Lung cancer screening with low dose CT scan']}], 'interventions': [{'name': 'Lung cancer screening with low dose CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Low dose CT scan in active smokers or ex-smokers with an age between 50 and 75 years old', 'armGroupLabels': ['Active smokers']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Juan Carlos Trujillo Reyes, MD/PHD', 'role': 'CONTACT', 'email': 'jtrujillo@santpau.cat', 'phone': '0034654032813'}, {'name': 'Luis Seijo Maceiras, MD/PHD', 'role': 'CONTACT', 'email': 'lseijo@unav.es'}], 'overallOfficials': [{'name': 'Juan Carlos Trujillo Reyes, MD/PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'ipdSharingStatementModule': {'url': 'http://cassandra.xolomon.com/Home?returnurl=%2f', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': '1, 3 years after the beginning and at the end of the study', 'ipdSharing': 'YES', 'description': 'We have a PI in each center enrolled to the project. More than 40 hospitals are enrolled to the CASSANDRA project', 'accessCriteria': 'PI of each centre enrolled to CASSANDRA have a passwords to access to the database'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Sociedad Española de Neumología y Cirugía Torácica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}