Lung Cancer Screening Implementation Project in the Brazilian Public Health Care System (LUSIP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 477
- 试验地点
- 1
- 主要终点
- • Proportion of negative cases on screening according to the Lung-RADS classification.
研究概览
简要总结
A prospective, longitudinal, single-arm interventional study of lung cancer screening.
详细描述
Main hypothesis: The tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease could leads to an increase in the proportion of false-positive cases resulting in unnecessary medical procedures, which represents a waste of resources and a risk for patients.
Main objective: To assess whether the percentage of false-positive cases with indication of biopsy after lung cancer screening with low-dose CT in high-risk smokers in a population with a high prevalence of granulomatous disease will be within the expected range according to other studies in the literature.
As there is robust evidence of the effectiveness of screening in reducing mortality from lung cancer, we expect the project to bring benefits to patients treated for image-detected lung cancer in the project, with reduced staging and a shorter time between diagnosis and treatment. Therefore , although the focus is on the safety of screening, the project will also monitor the cancer detection rate, which is a surrogate endpoint of effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order, to be eligible for the study, patients must fulfill all the following inclusion criteria:
- •Age between ≥50 and ≤80 years.
- •Be a current smoker or have quit 15 years ago or less.
- •Have participated or are currently participating in smoking cessation program.
- •Lifetime smoking exposure equal to or greater than 20 pack-year.
- •Provided signed informed consent (ICF)
排除标准
- •In order, to be exclude for the study, patients must at least one of the following exclusion criteria:
- •Contraindications to the screening examination: (claustrophobic or weighing more than 130 kgs).
- •Inability to climb 3 stair steps non-stop (36 steps).
- •Disabling dyspnea
- •Symptomatic (with signs and symptoms suspicious of breast cancer lung, namely):
- •pleuritic chest pain
- •rapidly progressive dyspnea of recent onset
- •hemoptysis
- •unexplained hoarseness, lasting more than 1 month.
- •bone pain
- •supraclavicular lymphadenopathy or cervical lymphadenopathy persistent
- •unexplained weight loss of 5% or more of weight in less than 6 months
- •Previous history of malignant neoplasm (excluding non-melanoma skin cancer) diagnosed less than 10 years before the date of the interview;
- •Patients with diagnostic of severe psychiatric disease
- •Immunosuppressed by illness or drugs.
- •Subjected to anterior lung resection even when determined due to an etiology other than malignant neoplasia.
- •Person with a serious terminal illness that contraindicates curative lung surgery.
结局指标
主要结局
• Proportion of negative cases on screening according to the Lung-RADS classification.
时间窗: Last 10 years
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
• Proportion of false-positives.
时间窗: Last 10 years
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
次要结局
- • Percentage of adherence to follow-up.(Last 10 years)
- • Prevalence of granulomatous disease in screening positive cases(Last 10 years)
- • Prevalence of incidental findings.(Last 10 years)
- • Willingness to be screened (ie, proportion of eligible patients actually signing up for the study)(Last 10 years)
- • Cancer detection rate.(last 10 years)
- • Percentage of adherence to screening - calculated by dividing the number of individuals screened with LDCT (numerator) by the number of eligible individuals invited to screen (denominator).(Last 10 years)
- • Prevalence of clinically relevant incidental findings that required follow-up.(Last 10 years)