Lung Cancer Screening Program in Mexico
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorInstituto Nacional de Cancerologia de Mexico
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
Subjects who cannot be examined by tomography due to physical limitations such as weight.
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.
Trial population
Mexican population aged over 50 years with lung cancer risk factors
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Screening
Other interventionAnnual 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).
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Screening1 intervention
Trial outcomes
Primary outcomes
1
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 inclusionSecondary outcomes
1
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 cancer2
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 cancerOther outcomes
1
Lung cancer clinical stage
Assess stage of the disease in patients detected by LDCT screening program
Time frame
Annually over 3-year from inclusion2
Serum immunological biomarkers
Assess Inflammatory cytokines
Time frame
Annually over 3-year from inclusion3
Nodule detection rate
Assess nodule detection rate, characteristics and outcomes detected at the screening protocol.
Time frame
Annually over 3-year from inclusion4
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 inclusionSponsors and contacts
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Source ClinicalTrials.gov