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NCT Number: NCT07524803

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

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CTIC, Bogotá, Colombia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ≥50 years of age and one of any of the following criteria:
  • Exposure to wood smoke (at least 100 hours per year)
  • A family history of lung cancer in first-degree relatives
  • A diagnosis of COPD and/or emphysema
  • Smokers with a tobacco index of 10 years or more

Exclusion criteria

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

Treatment and study plan

Chest X-Ray, Low Dose CT scan

Diagnostic Test

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)

  • Low risk by qXR and Lung RADS 1 or 2: repeat in 24 months
  • 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

Primary outcomes

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

    Time frame: From enrollment until 5 years of follow-up

Secondary outcomes

  1. Utility of qXR-LNMS of CXR for lung cancer risk assessment to exclude low risk patients from LDCT screening

    Time frame: From enrollment until 5 years of follow-up

  2. Utility of LDCT-based LC screening in subjects with various risk profiles in LATAM

    Time frame: From enrollment until 5 years of follow-up

  3. Prevalence of lung nodules in the study population

    Time frame: From enrollment until 5 years of follow-up

  4. Mortality rate in subjects diagnosed with an anomaly in the LDCT (with or without LC diagnosis)

    Time frame: From enrollment until 5 years of follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Corrales, MD

CONTACT

[email protected]

+506 40202222

Sponsors and collaborators

Lead sponsor

Latin American Consortium for the Lung Cancer Research

Other

Collaborators

  • Alexander Fleming Institute
  • 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

Registry information

Official study title

A Prospective Observational Study to Determine the Utility of Lung Cancer Screening for Early Detection of Suspicious Lung Nodules in Latin America

Acronym: LUCAS-LATAM

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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