The purpose of this study is to detetct Circulating tumor cells(CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) in patients with pulmonary nodules using a novel microfluidic CTC-detection system. Then construct an early diagnostic model for lung cancer.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: November 1, 2020
Patients found pulmonary nodules by CT screening will be enrolled in this study prospectively. CTCs and CAMLs both are cancer specific biomarkers found in the peripheral blood of patients with solid tumors including lung cancer. Through detecting CTCs and CAMLs in healthy volunteers and patients with pulmonary nodules who undergo biopsy, determine the cut-off value of the test. Further analysis of the test specificity and sensitivity, and on this basis construct an early diagnostic model for lung cancer.
Arms, Groups and Cohorts
- Healthy Volunteers
- Patients With Pulmonary Nodule
Clinical Trial Outcome Measures
- Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules
- Time Frame: 12 months
- The number of CTCs and CAMLs will be detected in the peripheral blood of patients with pulmonary nodules using a novel microfluidic CTC-detection system.
- Determination of optimal cut-off values for screening Lung Cancer paitents
- Time Frame: 6 months
- The optimal cut-off values will be determined by the ROC analyses.
Participating in This Clinical Trial
- Female or male, 18 years of age or older
- Pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
- Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Provider of Information About this Clinical Study
- Principal Investigator: Caicun Zhou, Director Head of Medical Oncology – Shanghai Pulmonary Hospital, Shanghai, China
- Overall Official(s)
- Yayi He, MD, PHD, Principal Investigator, Shanghai Pulmonary Hospital, Tongji University
- Overall Contact(s)
- Yayi He, MD, PHD, +862165115006, email@example.com
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