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

NCT07524803 | Not Yet Recruiting

• 1 other identifier: CLICAP-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lung cancer; screening; low dose CT scan; lung nodule

Outcome Measures

Primary Outcomes (1)

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

  From enrollment until 5 years of follow-up

Secondary Outcomes (4)

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

  From enrollment until 5 years of follow-up

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

  From enrollment until 5 years of follow-up

• Prevalence of lung nodules in the study population

  From enrollment until 5 years of follow-up

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

  From enrollment until 5 years of follow-up

Study Arms (1)

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

Interventions

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) 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

Healthy volunteers

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Latin American Consortium for the Lung Cancer Research: lead
• Centro de Investigacion y Manejo del Cancer (CIMCA): collaborator
• Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo: collaborator
• Alexander Fleming Institute: collaborator
• Instituto Nacional de Cancerologia de Mexico: collaborator

Study Sites (2)

CTIC

Bogotá, Colombia

Location

Centro de Investigacion y Manejo del Cancer (CIMCA)

San José, Provincia de San José, 10103, Costa Rica

Location

Related Publications (5)

• Carrot-Zhang J, Soca-Chafre G, Patterson N, Thorner AR, Nag A, Watson J, Genovese G, Rodriguez J, Gelbard MK, Corrales-Rodriguez L, Mitsuishi Y, Ha G, Campbell JD, Oxnard GR, Arrieta O, Cardona AF, Gusev A, Meyerson M. Genetic Ancestry Contributes to Somatic Mutations in Lung Cancers from Admixed Latin American Populations. Cancer Discov. 2021 Mar;11(3):591-598. doi: 10.1158/2159-8290.CD-20-1165. Epub 2020 Dec 2.

  PMID: 33268447 BACKGROUND

• Corrales L, Rosell R, Cardona AF, Martin C, Zatarain-Barron ZL, Arrieta O. Lung cancer in never smokers: The role of different risk factors other than tobacco smoking. Crit Rev Oncol Hematol. 2020 Apr;148:102895. doi: 10.1016/j.critrevonc.2020.102895. Epub 2020 Jan 31.

  PMID: 32062313 BACKGROUND

• Arrieta O, Zatarain-Barron ZL, Cardona AF, Corrales L, Martin C, Cuello M. Uniting Latin America Through Research: How Regional Research Can Strengthen Local Policies, Networking, and Outcomes for Patients With Lung Cancer. Am Soc Clin Oncol Educ Book. 2022 Apr;42:1-7. doi: 10.1200/EDBK_349951.

  PMID: 35503985 BACKGROUND

• Cardona AF, Sanchez N, Gutierrez-Babativa L, Rojas L, Zuluaga J, Martinez S, Viola L, Carvajal C, Bogoya J, Prieto-Pinto L, Samaca-Samaca D, Robles A, Kock J, Martin C, Corrales L, Raez LE, Cordeiro de Lima V, Samtani S, Arrieta O. Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data study. Lancet Reg Health Am. 2025 Jul 2;49:101172. doi: 10.1016/j.lana.2025.101172. eCollection 2025 Sep.

  PMID: 40688567 BACKGROUND

• Lam S, Bai C, Baldwin DR, Chen Y, Connolly C, de Koning H, Heuvelmans MA, Hu P, Kazerooni EA, Lancaster HL, Langs G, McWilliams A, Osarogiagbon RU, Oudkerk M, Peters M, Robbins HA, Sahar L, Smith RA, Triphuridet N, Field J. Current and Future Perspectives on Computed Tomography Screening for Lung Cancer: A Roadmap From 2023 to 2027 From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2024 Jan;19(1):36-51. doi: 10.1016/j.jtho.2023.07.019. Epub 2023 Jul 23.

  PMID: 37487906 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Diagnostic Imaging; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Luis Corrales, MD

  Consorcio Latinoamericano para la Investigacion en Cancer de Pulmon (CLICAP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Corrales, MD

CONTACT

+506 40202222; corrales@cimcacr.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CO (1)