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

Official title

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

Overview

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).

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 te

Primary outcome measures

• 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 outcome measures (4)

• 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]
• Utility of LDCT-based LC screening in subjects with various risk profiles in LATAM [Time frame: 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]
• 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]

Eligibility criteria

Inclusion criteria

1\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Colombia · 1 center

• CTIC — Bogotá

Costa Rica · 1 center

• Centro de Investigacion y Manejo del Cancer (CIMCA) — San José

Publications

• 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. PMID 33268447
• 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
• 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
• 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. Lanc PMID 40688567
• 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 PMID 37487906

Identifiers

NCT: NCT07524803 · CLICAP-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗