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| Name | Class |
|---|---|
| Centro de Investigacion y Manejo del Cancer (CIMCA) | OTHER |
| Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo | OTHER |
| Instituto Nacional de Cancerologia de Mexico | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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)
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
1. Men and women ≥50 years of age and one of any of the following criteria:
Exclusion Criteria:
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2000 patients will be recruited in 4 Latin American countries (Mexico 700 pts,Costa Rica 300 pts, Colombia 500 pts, Argentina 500 pts)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Corrales, MD | Contact | +506 40202222 | corrales@cimcacr.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis Corrales, MD | Consorcio Latinoamericano para la Investigacion en Cancer de Pulmon (CLICAP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTIC | Bogotá | Colombia |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33268447 | Background | 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. | |
| 32062313 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007090 | Image Interpretation, Computer-Assisted |
| D011856 | Radiographic Image Enhancement |
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| Alexander Fleming Institute | UNKNOWN |
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Plasma samples
|
| 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 |
| Centro de Investigacion y Manejo del Cancer (CIMCA) | San José | Provincia de San José | 10103 | Costa Rica |
|
| 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. |
| 35503985 | 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. |
| 40688567 | 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. |
| 37487906 | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |