A Single-center Study to Evaluate the Feasibility of a Novel NA-NOSE for Monitoring Response to and Detecting Recurrence After Surgery or Radiation in Early Stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Successful evaluation of gas samples taken from lung cancer patients
研究概览
简要总结
This clinical trial studies nanoscale artificial nose (NA-NOSE) in monitoring response and detecting recurrence after surgery or radiation therapy in patients with stage I or stage II non-small cell lung cancer (NSCLC). Using the NA-NOSE breath test may be an effective way to monitor response and detect recurrence of NSCLC after surgery or radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. Determine if a suitable fraction of patients become NA-NOSE negative within three years post treatment. We will test the hypothesis that this fraction is at most 30% versus the alternative that it is at least 50%.
SECONDARY OBJECTIVES:
I. Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE positive prior to clinical recurrence.
II. Estimate the time post treatment needed to become NA-NOSE negative. III. Estimate the lead time gained between a negative to positive NA-NOSE transition and clinical recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must either have histologic or pathologically confirmed non-small cell lung cancer (NSCLC) or suspicious nodules/lesions which are going to be surgically resected before they are pathologically confirmed
- •Patients must have stage I or II disease based on the parameters for staging NSCLC found in the American Joint Committee on Cancer (AJCC) cancer staging handbook seventh edition
- •Patients must be deemed to be eligible candidates for either surgery or stereotactic radiation
- •Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is allowed at the discretion of treating physician for the participating subject
- •Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Ability to travel to appointments and willingness to participate in this study
- •Ability to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form
排除标准
- •Patients who have had a prior lung cancer within the last five years from the current diagnosis
- •Patients having a prior malignancy within the past 3 years other than resected of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy
- •Patients with any prior systemic therapy for the current diagnosis of lung cancer
- •Patients with a diagnosis of advanced stage disease (stage III or IV)
- •Patients who are unable to comply with study and/or follow up procedures
- •Patients who have uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements
- •Patients who are pregnant or are breast feeding
研究组 & 干预措施
Treatment (NA-NOSE breath test)
Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2 pre-treatment samples), and post-treatment samples at regularly scheduled follow up visits, for 2 years in the absence of disease progression.
干预措施: breath test (Procedure)
Treatment (NA-NOSE breath test)
Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2 pre-treatment samples), and post-treatment samples at regularly scheduled follow up visits, for 2 years in the absence of disease progression.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Successful evaluation of gas samples taken from lung cancer patients
时间窗: Up to 3 years
Percent of patients that become nanoscale artificial nose negative within 3 years post-surgery
时间窗: Up to 3 years
We will test the null hypothesis that at most 30% of patients will become nanoscale artificial nose negative within 3 years post- surgery. The alternative will be that this fraction will be at least 50%. If at least 15/35 patients become nanoscale artificial nose negative within 3 years post treatment follow up we will reject the null. The test has 84.5% power and 7.31% type I error.
次要结局
- Time to become nanoscale artificial nose negative post treatment(Up to 3 years)
- Percentage of patients who become nanoscale artificial nose negative within 3 years and recur within that time frame that will become nanoscale artificial nose positive before recurrence(Up to 3 years)
- Lead time between the transition from nanoscale artificial nose negativity to positivity and clinical recurrence(Up to 3 years)