Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Enrollment
- 150
- Primary Endpoint
- Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Caicun Zhou
Director Head of Medical Oncology
Shanghai Pulmonary Hospital, Shanghai, China
Eligibility Criteria
Inclusion Criteria
- •Female or male, 18 years of age or older
- •Pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
Exclusion Criteria
- •Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Determination of optimal cut-off values for screening Lung Cancer paitents(6 months)