An observational study in Lung Cancer, sponsored by Instituto Nacional de Cancerologia de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Instituto Nacional de Cancerologia de Mexico · Observational
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.
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).
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).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Instituto Nacional de Cancerologia de Mexico is the lead sponsor of 41 studies on the registry; 13 are open to participants now.
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Mexican population aged over 50 years with lung cancer risk factors
Eligible participants over fifty years old and one of the next criteria:
Exclusion Criteria:
Elimination Criteria
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).
Other: 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).
Lung cancer incidence in Mexican population
Assess the number of lung cancer detections after each round of screening.
Time frame: Annually over 3-year from inclusion
Lung cancer survival
Assess lung cancer mortality in participants included in the screening protocol and outside the protocol.
Time frame: 10-year follow-up or death from lung cancer
All-cause mortality
Asses all-cause mortality related to risk factors at the 3-years of LDCT screening and follow-up
Time frame: 10-year follow-up or death from lung cancer
Lung cancer clinical stage
Assess stage of the disease in patients detected by LDCT screening program
Time frame: Annually over 3-year from inclusion
Serum immunological biomarkers
Assess Inflammatory cytokines
Time frame: Annually over 3-year from inclusion
Nodule detection rate
Assess nodule detection rate, characteristics and outcomes detected at the screening protocol.
Time frame: Annually over 3-year from inclusion
Chronic Obstructive Pulmonary disease (COPD) incidence rate
Detect participants with a positive spirometry test that covers COPD diagnosis
Time frame: Annually over 3-year from inclusion
Anxiety/Depression rate
Asses psychological diagnosis (anxiety/depression) related to a lung cancer screening program.
Time frame: Annually over 3-year from inclusion
Plan to share: No
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Instituto Nacional de Cancerologia de Mexico