肺 EpiCheck 生物标志物开发研究
This study is part of the development of a non-invasive lung cancer screening test which aim to identify early-stage lung cancer in patients at high risk for lung cancer.
研究概览
详细说明
This is a prospective, multi-center, observational nonsignificant risk study aimed to collect blood and clinical data from primary lung cancer and control subjects to characterize various biomarkers that will discriminate between lung cancer and control subjects.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Haifa、以色列
- Carmel Medical Center
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Tel Aviv、以色列
- Sourasky Medical Center
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Budapest、匈牙利
- National Koranyi Institute for Pulmonology
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Florida
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Miami、Florida、美国、33130
- Life Spring Clinical Research
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Panama City、Florida、美国、32405
- Emerald Coast OBGYN
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Louisiana
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Shreveport、Louisiana、美国、71106
- Ochsner LSU Health Shreveport - Regional Urology
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Michigan
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Southfield、Michigan、美国、48076
- Comprehensive Urology
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Troy、Michigan、美国、48084
- Michigan Institute of Urology, P.C.
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Texas
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San Antonio、Texas、美国、78229
- Urology San Antonio
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Hengelo、荷兰
- ZGT Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
All subjects should be without other cancer in the past 5 years except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
描述
Inclusion Criteria - Cases:
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
- Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology.
Exclusion Criteria - Cases
- Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer
Inclusion Criteria - USPSTF risk
- Age 50-80 years
- Subjects who are currently smoking or former smokers, with at least 20 pack-years
Exclusion Criteria - USPSTF risk
- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
Inclusion Criteria - Healthy controls
- Age 20-80 years
- Never smoker or current / previous smoker < 20 pack year history
Exclusion Criteria - Healthy Controls
- Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix.
- Not previously diagnosed with a lung lesion highly suspicious for cancer
- Under follow up or work up for any lesion suspicious for any type of cancer
- Presenting with fever with body temperature 100.4°F (38°C) or higher
- Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw
- Pregnancy
- Any history of blood product transfusion within 30 days prior to blood draw
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Cases Cohort
Subjects age 50-80 years old, with smoking history of at least 20 pack years with either (a) a high suspicion for lung cancer, who are planned to undergo biopsy or surgery to establish a definitive diagnosis after enrollment; or (b) confirmed primary lung cancer diagnosis, treatment naïve subjects. |
Blood collection |
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USPSTF At Risk - Control Cohort
Healthy subjects aged 50-80 years old with smoking history of at least 20 pack years. |
Blood collection |
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Healthy Control Cohort
Healthy subjects aged 20-80 years old which are non-smokers or with smoking history of less than 20 pack years. |
Blood collection |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Performance
大体时间：Day 1
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Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value). |
Day 1
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.