Specimens for Lung Cancer Panel Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Test performance
研究概览
简要总结
This is an observational study designed to determine the optimal combination of biomarkers and clinical data for the early detection, confirmation, and better treatment of lung cancer including minimizing recurrence.
详细描述
Peripheral venous blood and clinical data will be collected from consented subjects with lung nodules identified in radiology that are suspicious for lung cancer before invasive diagnosis or treatment is initiated. Various analyses will be conducted to determine which subset of biomarkers is most likely to be the most useful in the clinic. Attributes considered are accuracy (sensitivity, specificity, improvement over other methods) and ease of collection and transport. Results will not be reported to treating physicians and will not alter care of the patient.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient has at least one indeterminant nodule with a diameter greater than or equal to 5mm and a Mayo SPN risk greater than 5%, identified by radiology, that has not been biopsied or undergone surgery.
- •The patient and the treating physician intend to follow up on the nodule with a biopsy procedure, PET scan, or active surveillance, with the procedure or next surveillance planned within the next 7 months.
- •Ability to understand the study and sign an informed consent form
- •Relevant clinical data accessible
- •Ability and willingness to safely donate 40 mL of blood
- •Ability of the site to collect and process blood per protocol Exclusion
- •1. The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater.
- •2. The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary.
- •3. Previous cancer diagnosis of any origin.
- •Is currently pregnant
- •Is currently a prisoner or becomes a prisoner at any point during the study
- •Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf 6.2 Criteria for the previous cancer suspicious nodule arm
- •1. The patient has at least one indeterminant nodule with a diameter greater than or equal to 5mm and a Mayo SPN risk greater than 5%, identified by radiology, that has not been biopsied or undergone surgery.
- •2. The patient and the treating physician intend to follow up on the nodule with a biopsy procedure, PET scan, or active surveillance, with the procedure or next surveillance planned within the next 7 months.
- •3. The patient has been in remission for a previous cancer not of lung origin for more than 5 years.
- •4. Ability to understand the study and sign an informed consent form
- •Relevant clinical data accessible
- •Ability and willingness to safely donate 40 mL of blood
- •Ability of the site to collect and process blood per protocol Exclusion
- •The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater.
- •The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary.
- •Previous cancer diagnosis in the lung (either of lung origin or metastasis to the lung).
- •The treating physician believes the lung nodule is a recurrence of a previously diagnosed cancer.
- •Is currently pregnant
- •Is currently a prisoner or becomes a prisoner at any point during the study
- •Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf
- •6.3 Criteria for the healthy volunteer arm
- •Ability to understand the study and sign an informed consent form
- •Relevant clinical data accessible
- •Ability and willingness to safely donate up to 40 mL of blood
- •The ability of the site to collect and process blood per protocol Exclusion
- •1. Is currently pregnant
- •Is currently a prisoner or becomes a prisoner at any point during the study
- •Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf
排除标准
- 未提供
研究组 & 干预措施
Prior cancer
Prior cancer history
No prior cancer
Indeterminant lung nodules with no prior history of cancer
Healthy volunteers
Healthy volunteers
结局指标
主要结局
Test performance
时间窗: Two years from final case enrollment
Analytical validity, clinical validity, and clinical utility. Ability to correctly re-risk indeterminate nodules and ability to change clinical care based on hypothetical treatment plans for different test outcomes. Actual test results will not be provided to physicians, and actual care will not be affected.
次要结局
未报告次要终点