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

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 Overview

• Status: Unknown
• Conditions: Healthy; Pulmonary Nodule

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Yayi He, MD, PHD; Phone Number: +862165115006; Email: 2250601@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Volunteers
Patients With Pulmonary Nodule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules	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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: Yayi He, MD, PHD, Shanghai Pulmonary Hospital, Tongji University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: YT2019-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No