Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2022-03-24
2027-03-24
Brief Summary
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Detailed Description
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Secondary 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.
The 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).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Screening
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).
Screening
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).
Interventions
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Screening
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).
Eligibility Criteria
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Inclusion Criteria
* Current smokers (\>20 pack-years)
* Former smokers (\>20 pack-years) who have quit within the past 15 years,
* Non-smokers exposed to wood smoke more than 100 hours/year
* Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
Exclusion Criteria
* History of any type of cancer within the last five years, except non-melanoma skin cancer.
* Symptoms consistent with some malignant neoplasm.
* People with a poor physical-emotional condition that reduces their life expectancy or does not ensure adherence to the study.
Elimination Criteria
• Withdrawal of informed consent
50 Years
ALL
Yes
Sponsors
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Instituto Nacional de Cancerologia de Mexico
OTHER
Responsible Party
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Oscar Gerardo Arrieta Rodríguez
Head of Thoracic Oncology Unit
Principal Investigators
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Oscar G Arrieta, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cancerologia (INCan) Mexico
Locations
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Instituto Nacional de Cancerologia (INCan) Mexico
Mexico City, Tlalpan, Mexico
Countries
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Central Contacts
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Facility Contacts
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Oscar G Arrieta, M.D., M.Sc.
Role: primary
Marisol Arroyo-Hernández, M.D., M.Sc.
Role: backup
References
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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.
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.
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.
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.
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.
Other Identifiers
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(015/005/ICI)(CEI 946/15)
Identifier Type: -
Identifier Source: org_study_id