A Prospective Observational Study to Determine the Utility of Lung Cancer Screening for Early Detection of Suspicious Lung Nodules in Latin America
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Utility of LDCT-based lung cancer screening in identifying suspicious lung nodules in smokers and non-smokers across LATAM
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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)
- Low risk by qXR and Lung RADS 1 or 2: repeat in 24 months
- 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
干预措施: Chest X-Ray, Low Dose CT scan (Diagnostic Test)
结局指标
主要结局
Utility of LDCT-based lung cancer screening in identifying suspicious lung nodules in smokers and non-smokers across LATAM
时间窗: From enrollment until 5 years of follow-up
次要结局
- 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)