Lung Cancer Early Detection With Low-dose Computed Tomography in High-risk Individuals: Experience in Mexico
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Lung cancer incidence in Mexican population
研究概览
简要总结
This prospective study aims to detect early-stage lung cancer using low-dose computed tomography (LDCT) in Mexicans aged 50 or older who are current or former heavy smokers, non-smokers exposed to significant wood smoke, or diagnosed with COPD. Annual LDCT, spirometry, and serum biomarker tests will be conducted over 3 years, and a follow-up lasting up to 10 years.
详细描述
This prospective cohort study aims to detect lung cancer in early stages using LDCT scans in Mexican individuals aged 50 years or older. Eligible participants comprise current smokers with a history of ≥ 20 pack-years, former smokers who have quit within the past 15 years, non-smokers exposed to wood smoke more than 100 hours/year, or patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
Secondary objectives include assessing the 10-year mortality rate, the association of lung cancer with immunologic biomarkers, the demographic characterization of participants, the psychological impact of an LC screening program, the histological profiling of positive cases, lung function changes in at-risk individuals, and the clinical staging distribution at diagnosis.
The study will conduct annual LDCT scans, lung function tests (spirometry), anxiety and depression assessments, and serum biomarkers tests over 3 years. Positive LDCT results will adhere to LUNG-RADS guidelines and be managed by a multidisciplinary team. Prevention strategies, including tobacco cessation treatments, will be provided. Follow-up will continue for 5 and 10 years or until an event of completion occurs (cancer diagnosis, end of follow-up, or death).
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
- •Eligible participants over fifty years old and one of the next criteria:
- •Current smokers (>20 pack-years)
- •Former smokers (>20 pack-years) who have quit within the past 15 years,
- •Non-smokers exposed to wood smoke more than 100 hours/year
- •Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
排除标准
- •Subjects who cannot be examined by tomography due to physical limitations such as weight.
- •History of any type of cancer within the last five years, except non-melanoma skin cancer.
- •Symptoms consistent with some malignant neoplasm.
- •People with a poor physical-emotional condition that reduces their life expectancy or does not ensure adherence to the study.
- •Elimination Criteria
- •Withdrawal of informed consent
结局指标
主要结局
Lung cancer incidence in Mexican population
时间窗: Annually over 3-year from inclusion
Assess the number of lung cancer detections after each round of screening.
次要结局
- All-cause mortality(10-year follow-up or death from lung cancer)
- Lung cancer survival(10-year follow-up or death from lung cancer)
研究者
Oscar Gerardo Arrieta Rodríguez
Head of Thoracic Oncology Unit
Instituto Nacional de Cancerologia de Mexico