A Prospective Observational Study to Determine the Utility of Lung Cancer Screening for Early Detection of Suspicious Lung Nodules in Latin America
Trial ID: NCT07524803
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-05-01
Completion date: 2032-05-01
Sponsor: Latin American Consortium for the Lung Cancer Research
Collaborators: Centro de Investigacion y Manejo del Cancer (CIMCA); Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo; Instituto Nacional de Cancerologia de Mexico; Alexander Fleming Institute
Conditions: Lung Cancer Screening
Interventions: Chest X-Ray, Low Dose CT scan
Locations: CTIC; Centro de Investigacion y Manejo del Cancer (CIMCA)
Countries: Colombia; Costa Rica
Enrollment: 2000
Age range: 50 Years - None
Sex: ALL

Summary:
Prospective study to assess lung cancer screening with low dose CT scan (LDCT) in Latin America (LATAM) and prospectively evaluate chest-XRay analyzed with artificial intelligence (AI) using qXRin (QURE ai) at the initial visit correlating with the findins of the initial LDCT in patients with other high risk criteria to develop lung cancer. 2000 patients will be recruited in 4 LATAM countries (Mexico 700 pts, Costa Rica 300 pts, Colombia 500 pts, Argentina 500 pts). All patients will be ≥50years of age with one of the following additional inclusion criteria: a. exposure to wood smoke (at least 100 hours/year), b.family history of lung cancer in a first degree relative, c. COPD and/or emphysema, d. smokers with a tobacco index of 10 y or more. The exclusion criteria include: a. lung cancer diagnosis or other type of cancer 5 years prior to screening, b. loss of 10% of baseline weight 6 months before inclusion, c. ineligible for LDCT, d. life expectancy ≤5 years, and e. previous history of pulmonary nodules.

The primary objective of the study is the utility of LDCT-based lung cancer screening in identifying suspicious lung nodules in smokers and non-smokers across LATAM, with secondary objectives including: 1- Utility of qXR-LNMS (lung nodule malignancy score) of chest XRay for lung cancer risk assessment to exclude low risk patients from LDCT screening, 2- Utility of LDCT-based lung cancer screening in subjects with various risk profiles in LATAM, 3- Prevalence of lung nodules in the study population, 4-Mortality rate in the subjects diagnosed with an anomaly in the LDCT (with or without LC diagnosis).

Eligibility criteria:
Inclusion Criteria:

1\. Men and women ≥50 years of age and one of any of the following criteria:

1. Exposure to wood smoke (at least 100 hours per year)
2. A family history of lung cancer in first-degree relatives
3. A diagnosis of COPD and/or emphysema
4. Smokers with a tobacco index of 10 years or more

Exclusion Criteria:

1. Lung cancer diagnosis or any other type of active cancer during the 5 years prior to the screening
2. Incomplete clinical information
3. Loss of 10% of the baseline weight during 6 months prior to study entry
4. Having a functional status, psychiatric condition or comorbidity that precludes curative treatment
5. Any situation that makes the subject ineligible for LDCT
6. Life expectancy ≤5 years
7. Subjects with previous history of pulmonary nodules.

Outcomes:
Utility of LDCT-based lung cancer screening in identifying suspicious lung nodules in smokers and non-smokers across LATAM