Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer

• Conditions: Healthy; Pulmonary Nodule

• Registration Number: NCT04156360
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Study First Submitted: 2019-10-28
• Status Verified: 2019-11
• Study Start: 2019-11-01
• Study First Submitted QC: 2019-11-05
• Last Update Submitted: 2019-11-05
• Study First Posted: 2019-11-07
• Last Update Posted: 2019-11-07
• Primary Completion: 2020-11-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules	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 Outcome Measures

Name	Time	Method
Determination of optimal cut-off values for screening Lung Cancer paitents	6 months	The optimal cut-off values will be determined by the ROC analyses.