Feasibility Study of Lung Cancer Screening Using Cell-Free DNA Liquid Biopsy at Home in High-Risk Current and Former Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Screening preference
研究概览
简要总结
This clinical trial investigates how practical and doable (feasibility) cell-free deoxyribonucleic acid (DNA) liquid biopsy is in screening high-risk patients for lung cancer. Currently, a low dose computed tomography (CT) scan is used to screen for lung cancer, however, due to various factors, few high-risk patients are screened. Liquid biopsy utilizes technology that can detect small amounts of DNA shed by cancer cells and may be able to spot lung cancer at an earlier stage. If a positive result comes back from the liquid biopsy, a patient may be more willing to get a low dose CT (LDCT) scan, possibly confirming the biopsy's findings and thus leading to more early lung cancer detection.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of lung cancer screening using liquid biopsy in a community setting.
SECONDARY OBJECTIVES:
I. To determine screening follow-through rates in those who agreed to undergo screening by preferred modality (liquid biopsy versus [vs] LDCT).
II. To determine the rate of LDCT following liquid biopsy (in those who underwent liquid biopsy) after stratifying by test result (negative versus positive).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- 是
入选标准
- •Documented written informed consent of the participant.
- •Age 50-80 years.
- •Smoking history of >= 20 pack-years and if quit, quit within 15 years.
- •Received referral for counseling for lung cancer screening and would qualify for LDCT.
- •Health Insurance that will pay for a LDCT for lung cancer screening at either City of Hope Duarte, Newport Beach (Newport Diagnostic Imaging), or Lancaster (Renaissance Imaging/Antelope Valley Outpatient Imaging Center).
- •Willingness to provide blood sample.
- •English speaking.
- •Consent to undergo lung cancer screening with either liquid biopsy (LB) or LDCT.
排除标准
- •Symptoms of lung cancer.
- •Chest CT scan or chest positron emission tomography (PET)/CT within 12 months.
- •Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer.
- •Unable to undergo LDCT at either City of Hope Duarte, Newport Beach, or Lancaster.
结局指标
主要结局
Screening preference
时间窗: Upon completion of home liquid biopsy or LDCT, an average of 4 weeks.
The proportion of participants who agree to undergo lung cancer screening using liquid biopsy versus LDCT, with a feasibility threshold of at least 30% preferring liquid biopsy.
次要结局
- Survey scores across screening preference 2(At 6 month follow up)
- Survey scores across screening preference 4(At 6 month follow up)
- Survey scores across screening preference 5(At 6 month follow up)
- Participants who follow-through on screening 1(6 month follow-up timepoint.)
- Participants who follow-through on screening 4(6 month follow-up timepoint.)
- Participants who undergo low dose computed tomography of the chest (LDCT) after receiving liquid biopsy results(Up to 6 months)
- Survey scores across screening preference 3(At 6 month follow up)
- Participants who follow-through on screening 2(6 month follow-up timepoint.)
- Participants who follow-through on screening 3(6 month follow-up timepoint.)
- Sociodemographic factors (age, sex, race/ethnicity, educational background)(At baseline visit)
- Survey scores across screening preference 1(At 6 month follow up)