Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 6
- 主要终点
- Sensitivity and specificity of ct-DNA LUNAR Assay
研究概览
简要总结
This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.
详细描述
Study objectives and statistical approaches to achieve those objectives are determined at the level of the populations described below:
Population 1: Sensitivity and Specificity Thresholding.
In this phase, the technical feasibility of the intended use case will be assessed in the intended use population relative to known cancer status as established by standard clinical methods. ctDNA samples from enrolled patients will be assessed in each of the following cohorts:
Cohort 1A: High-risk patients negative for lung cancer by CT screening and clinical follow-up.
Cohort 1B: Patients with lung nodules ≥6 mm by CT but negative for lung cancer by extended (3 years) CT screening follow-up.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Ability to understand and provide written informed consent
- •Willingness to comply with study protocols and provide blood samples.
- •Willingness to complete 3-year clinical follow up
排除标准
- •Active non-cutaneous malignancy within the past 5 years as per medical record or patient report.
- •Exclusion criteria for possible follow-up visit blood draw:
- •Anemia - measured by hematocrit level of less than 30%, measured after the first blood draw.
- •Malnourishment - determined by BMI less than
- •If subject has BMI greater or equal to 19, but has a history of malnourishment, study staff will measure albumin level of subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg per deciliter, or subject will be excluded.
- •Severe Chronic Obstructive Pulmonary Disease (COPD) - defined by Gold Stage IV.
- •Unstable heart conditions - defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active congestive heart failure, ischemic cardiomyopathy, or history of complications because of previous blood donation.
- •Liver cirrhosis.
结局指标
主要结局
Sensitivity and specificity of ct-DNA LUNAR Assay
时间窗: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion\* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up\*\*. \*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.
Prospective negative predictive value of ct-DNA LUNAR assay
时间窗: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).
次要结局
未报告次要终点