Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules

Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells(CTC) in Benign and Malignant Lung Nodules

By testing the CTC number of new solitary pulmonary nodule patient, evaluating the correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the correlation of CTC number and the size of lung nodules of the malignant patients, the correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC and tumor markers will be detected before the patient received treatment. Tumor markers include Pro-GRP, NSE, CEA, CYFRA211, SCC.

Study Overview

• Status: Unknown
• Conditions: Solitary Pulmonary Nodule

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

New Solitary Pulmonary Nodule

Description

Inclusion Criteria:

• New Solitary Pulmonary Nodule patients
• first visit patient
• Heart, liver and kidney function is normal.
• 18-80 years old.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Blood collection time is not in the scheduled time.
• The plasma sample hemolysis or condensation.
• Whole blood samples less than 3 ml.
• poor compliance

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of circulating tumor cells will be detected in baseline by Immunomagnetic negative screening and targeted polymerase chain reaction(PCR) method.	The 3 mL of blood will be taked with each patient for CTCs detection.	1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concentration of the tumor marker of pro gastrin releasing peptide(Pro-GRP) will be detected in baseline by Electrochemical luminescence.	The 2 mL of serum will be extracted.	1 months
The concentration of the tumor marker of neurone specific enolase(NSE) will be detected in baseline by Electrochemical luminescence.	The 2 mL of serum will be extracted.	1 months
The concentration of the tumor marker of carcinoembryonic antigen(CEA) will be detected in baseline by Electrochemical luminescence.	The 2 mL of serum will be extracted.	1 months
The concentration of the tumor marker of cytokeratin 19 fragments(CYFRA211) will be detected in baseline by Electrochemical luminescence.	The 2 mL of serum will be extracted.	1 months
The concentration of the tumor marker of squamous cell carcinoma antigen(SCC) will be detected in baseline by Electrochemical luminescence.	The 2 mL of serum will be extracted.	1 months

Collaborators and Investigators

• Sponsor: GenoSaber
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: January 3, 2016
• First Submitted That Met QC Criteria: January 10, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 10, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: PCR; CTC
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Neoplasm Metastasis; Multiple Pulmonary Nodules; Neoplastic Cells, Circulating; Solitary Pulmonary Nodule
• Other Study ID Numbers: CTC2015-02