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

Shanghai Pulmonary Hospital, Shanghai, China

Status: Unknown

Conditions: Healthy; Pulmonary Nodule

Study type: Observational

Funder types: Other

Identifiers

NCT04156360

YT2019-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Healthy Volunteers

Patients With Pulmonary Nodule