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

Solitary Pulmonary Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02653859
• Other study ID #: CTC2015-02
• Status: Not yet recruiting
• Phase: N/A
• First received: January 3, 2016
• Last updated: January 10, 2016
• Start date: January 2016

Study information

• Verified date: October 2015
• Source: GenoSaber
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Neoplastic Cells, Circulating
• Solitary Pulmonary Nodule

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GenoSaber	Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No