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NCT04156360 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04156360
Other study ID # YT2019-001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date June 1, 2021

Study information
Verified date November 2019
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact Yayi He, MD, PHD
Phone +862165115006
Email 2250601@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date June 1, 2021
Est. primary completion date November 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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