Lung Cancer
Conditions
Keywords
Lung cancer screening, Early detection, Lung cancer, Low-dose CT, High-risk population
Brief summary
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.
Detailed description
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).
Interventions
OTHERScreening
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).
Sponsors
Instituto Nacional de Cancerologia de Mexico
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligible participants over fifty years old and one of the next 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
* 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. Elimination Criteria • Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung cancer incidence in Mexican population | Annually over 3-year from inclusion | Assess the number of lung cancer detections after each round of screening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung cancer survival | 10-year follow-up or death from lung cancer | Assess lung cancer mortality in participants included in the screening protocol and outside the protocol. |
| All-cause mortality | 10-year follow-up or death from lung cancer | Asses all-cause mortality related to risk factors at the 3-years of LDCT screening and follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chronic Obstructive Pulmonary disease (COPD) incidence rate | Annually over 3-year from inclusion | Detect participants with a positive spirometry test that covers COPD diagnosis |
| Serum immunological biomarkers | Annually over 3-year from inclusion | Assess Inflammatory cytokines |
| Anxiety/Depression rate | Annually over 3-year from inclusion | Asses psychological diagnosis (anxiety/depression) related to a lung cancer screening program. |
| Lung cancer clinical stage | Annually over 3-year from inclusion | Assess stage of the disease in patients detected by LDCT screening program |
| Nodule detection rate | Annually over 3-year from inclusion | Assess nodule detection rate, characteristics and outcomes detected at the screening protocol. |
Countries
Mexico
Contacts
Primary ContactOscar G Arrieta, M.D., M.Sc.
Backup ContactMarisol Arroyo Hernández, M.D.
Outcome results
None listed