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Lung Cancer Screening for Early Detection of Suspicious Lung Nodules in Latin America(LUCAS-LATAM)

NCT07524803 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2026-04-13

No results posted yet for this study

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).

Conditions

  • Lung Cancer Screening

Interventions

DIAGNOSTIC_TEST

Chest X-Ray, Low Dose CT scan

Visit 1: chest XRay analyzed by qXR (QURE ai) and LDCT1 Visit 2: LDCT2 : (12/24 months as applicable ± 2 weeks)(interval of LDCT2 is determined by the findings of the Visit 1) 1. Low risk by qXR and Lung RADS 1 or 2: repeat in 24 months 2. Low risk by qXR and Lung RADS 3, high risk by qXR and Lung RADS 1, 2, 3: repeat in 12 months Telephonic follow-up visits (at 6 month interval post LDCT2 for 2 years) Any Lung RADS 0, 4A, 4B, 4X or S will be assed in a thoracic oncology multidisciplinary team

Sponsors & Collaborators

  • Centro de Investigacion y Manejo del Cancer (CIMCA)

    collaborator OTHER

  • Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

    collaborator OTHER

  • Instituto Nacional de Cancerologia de Mexico

    collaborator OTHER

  • Alexander Fleming Institute

    collaborator UNKNOWN

  • Latin American Consortium for the Lung Cancer Research

    lead OTHER

Principal Investigators

  • Luis Corrales, MD · Consorcio Latinoamericano para la Investigacion en Cancer de Pulmon (CLICAP)

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2030-05-01
Completion
2032-05-01

Countries

  • Colombia
  • Costa Rica

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524803 on ClinicalTrials.gov