小 RNA 血液检测对低剂量 CT 肺癌筛查阳性后接受随访成像的患者的诊断性能
小 RNA 血液检测对低剂量 CT 肺癌阳性筛查后接受随访成像的患者的诊断性能“基于小 RNA 特征的肺癌早期检测 - 波士顿 II”
2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.
研究概览
详细说明
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.
Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.
Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.
研究类型
注册 (估计的)
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30342
- Northside Hospital
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Louisiana
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Baton Rouge、Louisiana、美国、70808
- Our Lady of the Lake Regional Medical Center
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Massachusetts
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Boston、Massachusetts、美国、02115
- Mass General Hospital
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Boston、Massachusetts、美国、02108
- Brigham and Women's Hospital
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Worcester、Massachusetts、美国、01655
- UMass Chan Medical School/UMass Memorial Health
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Health
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New York
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Queens、New York、美国、10461
- New York Health + Elmhurst Hospitals
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The Bronx、New York、美国、10461
- Jacobi Medical Center
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Pennsylvania
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DuBois、Pennsylvania、美国、15801
- Clinical Research Associates of Central PA
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Texas
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Beaumont、Texas、美国、77701
- Baptist Hospitals of Southeast Texas
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Utah
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Salt Lake City、Utah、美国、84112
- University Of Utah Health
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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
Individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.
描述
Inclusion Criteria:
- Adult male and female patients, aged 50 to 80 years
- Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
- Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
- Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
- Able and willing to provide informed consent
Exclusion Criteria:
- Prior history of diagnosed lung cancer
- History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
- Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
- Immunosuppressive medication
- Deemed not able to participate in the study by the investigator
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Participants undergoing diagnostic evaluation following positive LDCT screening
Participants undergoing further diagnostic evaluation following a positive LDCT lung cancer screening result. A blood sample is collected at enrollment, prior to any invasive diagnostic procedure or treatment, for evaluation of a small RNA-based lung cancer assay. Participants are followed to determine the final clinical diagnosis. |
At study enrollment, a blood sample is collected prior to any invasive diagnostic procedure or treatment. A small RNA-based lung cancer assay is performed on the collected blood sample for research purposes. Assay results are not returned to participants or investigators and are not used for clinical decision-making. |
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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Primary Objective
大体时间：1 year
|
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study. |
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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.