Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-07 @ 7:40 AM
Study NCT ID:
NCT06535451
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Cancer Screening Program in Mexico
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': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lung cancer clinical stage', 'timeFrame': 'Annually over 3-year from inclusion', 'description': 'Assess stage of the disease in patients detected by LDCT screening program'}, {'measure': 'Serum immunological biomarkers', 'timeFrame': 'Annually over 3-year from inclusion', 'description': 'Assess Inflammatory cytokines'}, {'measure': 'Nodule detection rate', 'timeFrame': 'Annually over 3-year from inclusion', 'description': 'Assess nodule detection rate, characteristics and outcomes detected at the screening protocol.'}, {'measure': 'Chronic Obstructive Pulmonary disease (COPD) incidence rate', 'timeFrame': 'Annually over 3-year from inclusion', 'description': 'Detect participants with a positive spirometry test that covers COPD diagnosis'}, {'measure': 'Anxiety/Depression rate', 'timeFrame': 'Annually over 3-year from inclusion', 'description': 'Asses psychological diagnosis (anxiety/depression) related to a lung cancer screening program.'}], 'primaryOutcomes': [{'measure': 'Lung cancer incidence in Mexican population', 'timeFrame': 'Annually over 3-year from inclusion', 'description': 'Assess the number of lung cancer detections after each round of screening.'}], 'secondaryOutcomes': [{'measure': 'Lung cancer survival', 'timeFrame': '10-year follow-up or death from lung cancer', 'description': 'Assess lung cancer mortality in participants included in the screening protocol and outside the protocol.'}, {'measure': 'All-cause mortality', 'timeFrame': '10-year follow-up or death from lung cancer', 'description': 'Asses all-cause mortality related to risk factors at the 3-years of LDCT screening and follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer screening', 'Early detection', 'Lung cancer', 'Low-dose CT', 'High-risk population'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '8080679', 'type': 'BACKGROUND', 'citation': 'Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635-42. doi: 10.1016/0959-8049(94)90535-5.'}, {'pmid': '33407290', 'type': 'BACKGROUND', 'citation': 'Arroyo-Hernandez M, Maldonado F, Lozano-Ruiz F, Munoz-Montano W, Nunez-Baez M, Arrieta O. Radiation-induced lung injury: current evidence. BMC Pulm Med. 2021 Jan 6;21(1):9. doi: 10.1186/s12890-020-01376-4.'}, {'pmid': '36130340', 'type': 'BACKGROUND', 'citation': 'Arroyo-Hernandez M, Alva-Lopez LF, Rendon A, Barroso-Villafuerte FR, Baez-Saldana R, Corona-Cruz JF, Farfan-Salazar G, Guerrero-Ixtlahuac J, Castillo-Gonzalez P, Salmon-Demongin A, Zaldivar-Crosby G, Bolano-Guerra LM, Zavala-Cruz GG, Sanchez-Gutierrez A, Rendon-Ramirez EJ, Magdaleno-Maldonado GE, Olivares-Torres CA, Lopez-Saucedo RA, Lizardo-Rodriguez AE, Ortiz-Vazquez S, Vazquez-Garcia J, Montes-Narvaez G, Pacheco-Juarez M, Arrieta-Rodriguez OG. Guia de Practica Clinica para el diagnostico temprano y la referencia oportuna del cancer de pulmon. Salud Publica Mex. 2022 Aug 26;64(5, sept-oct):530-538. doi: 10.21149/13919. Spanish.'}, {'pmid': '31276351', 'type': 'BACKGROUND', 'citation': 'Arroyo-Hernandez M, Zinser-Sierra JW, Vazquez-Garcia JC. [Lung-cancer screening program in Mexico]. Salud Publica Mex. 2019 May-Jun;61(3):347-351. doi: 10.21149/10326. Spanish.'}, {'pmid': '38977146', 'type': 'BACKGROUND', 'citation': 'Arrieta O, Arroyo-Hernandez M, Soberanis-Pina PD, Viola L, Del Re M, Russo A, de Miguel-Perez D, Cardona AF, Rolfo C. Facing an un-met need in lung cancer screening: The never smokers. Crit Rev Oncol Hematol. 2024 Oct;202:104436. doi: 10.1016/j.critrevonc.2024.104436. Epub 2024 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'This prospective study aims to detect early-stage lung cancer using low-dose computed tomography (LDCT) in Mexicans aged 50 or older who are current or former heavy smokers, non-smokers exposed to significant wood smoke, or diagnosed with COPD. Annual LDCT, spirometry, and serum biomarker tests will be conducted over 3 years, and a follow-up lasting up to 10 years.', 'detailedDescription': 'This prospective cohort study aims to detect lung cancer in early stages using LDCT scans in Mexican individuals aged 50 years or older. Eligible participants comprise current smokers with a history of ≥ 20 pack-years, former smokers who have quit within the past 15 years, non-smokers exposed to wood smoke more than 100 hours/year, or patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).\n\nSecondary objectives include assessing the 10-year mortality rate, the association of lung cancer with immunologic biomarkers, the demographic characterization of participants, the psychological impact of an LC screening program, the histological profiling of positive cases, lung function changes in at-risk individuals, and the clinical staging distribution at diagnosis.\n\nThe study will conduct annual LDCT scans, lung function tests (spirometry), anxiety and depression assessments, and serum biomarkers tests over 3 years. Positive LDCT results will adhere to LUNG-RADS guidelines and be managed by a multidisciplinary team. Prevention strategies, including tobacco cessation treatments, will be provided. Follow-up will continue for 5 and 10 years or until an event of completion occurs (cancer diagnosis, end of follow-up, or death).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mexican population aged over 50 years with lung cancer risk factors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible participants over fifty years old and one of the next criteria:\n\n* Current smokers (\\>20 pack-years)\n* Former smokers (\\>20 pack-years) who have quit within the past 15 years,\n* Non-smokers exposed to wood smoke more than 100 hours/year\n* Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).\n\nExclusion Criteria:\n\n* Subjects who cannot be examined by tomography due to physical limitations such as weight.\n* History of any type of cancer within the last five years, except non-melanoma skin cancer.\n* Symptoms consistent with some malignant neoplasm.\n* People with a poor physical-emotional condition that reduces their life expectancy or does not ensure adherence to the study.\n\nElimination Criteria\n\n• Withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT06535451', 'acronym': 'DETECTO', 'briefTitle': 'Lung Cancer Screening Program in Mexico', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cancerologia de Mexico'}, 'officialTitle': 'Lung Cancer Early Detection With Low-dose Computed Tomography in High-risk Individuals: Experience in Mexico', 'orgStudyIdInfo': {'id': '(015/005/ICI)(CEI 946/15)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening', 'description': 'Current smokers (\\>20 pack-years) or have quit within the past 15 years, non-smokers exposed to wood smoke more than 100 hours/year, or participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD).', 'interventionNames': ['Other: Screening']}], 'interventions': [{'name': 'Screening', 'type': 'OTHER', 'description': 'Annual LDCT, lung function test (spirometry), anxiety/depression assessments, and serum biomarkers tests over 3 years. Follow-up will continue for 5 and 10 years or until event completion (cancer diagnosis, end of follow-up, or death).', 'armGroupLabels': ['Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Tlalpan', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Oscar G Arrieta, M.D., M.Sc.', 'role': 'CONTACT', 'email': 'ogarrieta@gmail.com', 'phone': '5556280400', 'phoneExt': '44001'}, {'name': 'Marisol Arroyo-Hernández, M.D., M.Sc.', 'role': 'CONTACT', 'email': 'marisol.neumologia@gmail.com', 'phone': '5556280400'}], 'facility': 'Instituto Nacional de Cancerologia (INCan) Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Oscar G Arrieta, M.D., M.Sc.', 'role': 'CONTACT', 'email': 'ogarrieta@gmail.com', 'phone': '5556280400', 'phoneExt': '44001'}, {'name': 'Marisol Arroyo Hernández, M.D.', 'role': 'CONTACT', 'email': 'marisol.neumologia@gmail.com', 'phone': '5556280400'}], 'overallOfficials': [{'name': 'Oscar G Arrieta, M.D., M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Cancerologia (INCan) Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cancerologia de Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Thoracic Oncology Unit', 'investigatorFullName': 'Oscar Gerardo Arrieta Rodríguez', 'investigatorAffiliation': 'Instituto Nacional de Cancerologia de Mexico'}}}}