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

Latin American Consortium for the Lung Cancer Research

Status: Not yet enrolling

Conditions: Lung Cancer Screening

Treatments: Diagnostic Test: Chest X-Ray, Low Dose CT scan

Study type: Observational

Funder types: Other

Identifiers

NCT07524803

CLICAP-001

Details and patient eligibility

About

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).

Enrollment: 2,000 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

Healthy volunteers

Description:

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

Treatment:

Diagnostic Test: Chest X-Ray, Low Dose CT scan