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

April 6, 2026 updated by: Latin American Consortium for the Lung Cancer Research

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
  • Costa Rica
    • Provincia de San José
      • San José, Provincia de San José, Costa Rica, 10103
        • Centro de Investigacion y Manejo del Cancer (CIMCA)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

2000 patients will be recruited in 4 Latin American countries (Mexico 700 pts,Costa Rica 300 pts, Colombia 500 pts, Argentina 500 pts)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers

2000 patients in 4 LATAM countries, ≥50years of age with one of the following: a. exposure to wood smoke (at least 100 hours/year), b.family history of LC in a first degree relative, c. COPD and/or emphysema, d. smokers with a tobacco index of 10 y or more. Patients will have the following interventios and follow-up: A- Visit 1: chest XRay analyzed by qXR and a LDCT1 B- 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 C- 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment until 5 years of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment until 5 years of follow-up
Utility of LDCT-based LC screening in subjects with various risk profiles in LATAM
Time Frame: From enrollment until 5 years of follow-up
From enrollment until 5 years of follow-up
Prevalence of lung nodules in the study population
Time Frame: From enrollment until 5 years of follow-up
From enrollment until 5 years of follow-up
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
From enrollment until 5 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Consortium for the Lung Cancer Research

Collaborators

Instituto Nacional de Cancerologia de Mexico
Alexander Fleming Institute
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Centro de Investigacion y Manejo del Cancer (CIMCA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2032

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLICAP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer Screening

Clinical Trials on Chest X-Ray, Low Dose CT scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe