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

Overview

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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2020

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.

Arms, Groups and Cohorts

  • Healthy Volunteers
  • Patients With Pulmonary Nodule

Clinical Trial Outcome Measures

Primary 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.

Secondary Measures

  • 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

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • 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, 2250601@qq.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.