CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11,935
- 试验地点
- 67
- 主要终点
- Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
研究概览
简要总结
CASCADE-LUNG is a multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population. The primary objective is to demonstrate the performance characteristics, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the DELFI Lung Cancer Screening Test (DLCST).
详细描述
DELFI identifies circulating tumor DNA (ctDNA) to detect cancer. Participants will be enrolled into the DELFI-L201 study after informed consent and eligibility is confirmed. The study purpose is to validate the performance of the DELFI-based test for the detection of lung cancer among individuals eligible for routine lung cancer screening. Participants will have blood collected and medical record review at baseline and will have medical record reviews at additional timepoints.
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
- 否
入选标准
- •All subjects
- •Ability to understand and provide written informed consent
- •Age ≥ 50 years
- •Current or former smoker
- •≥ 20 pack-years (pack years = number of packs per day × number of years smoked)
- •An initial or annual follow-up lung cancer screening chest CT planned/scheduled within 30 days after enrollment (i.e., enrollment chest CT scan)
排除标准
- •All subjects
- •Evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment
- •Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies)
- •Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment
- •Any history of organ tissue transplantation
- •Any history of blood product transfusion within 120 days prior to enrollment
- •Current pregnancy
- •Any condition that in the opinion of the Investigator should preclude the participant's participation in the study
- •Past or current participation in any clinical study sponsored by DELFI Diagnostics or any history of a LDT (Laboratory Developed Test) for early detection of lung cancer by DELFI Diagnostics
结局指标
主要结局
Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.
时间窗: Approximately 24 months
次要结局
- Performance characteristics (sensitivity, specificity, PPV, NPV) of the DLCST.(Up to approximately 36 months)
- Adverse events (AEs) associated with the blood specimen collection.(Point in time blood collection (1 day) at enrollment)