Lung Cancer Screening Program in Mexico (DETECTO)

Instituto Nacional de Cancerologia de Mexico

Status: Enrolling

Conditions: Lung Cancer

Treatments: Other: Screening

Study type: Observational

Funder types: Other

Identifiers

NCT06535451

(015/005/ICI)(CEI 946/15)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

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).

Treatment:

Other: Screening