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

Sponsor

GenoSaber (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02653859

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Enrollment

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Solitary Pulmonary Nodule

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

May 1, 2016

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

GenoSaber
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GenoSaber

ClinicalTrials.gov Identifier:

NCT02653859

Other Study ID Numbers:

CTC2015-02

First Posted:

Jan 12, 2016

Last Update Posted:

Jan 12, 2016

Last Verified:

Oct 1, 2015

Keywords provided by GenoSaber

CTC

PCR

Additional relevant MeSH terms:

Neoplastic Cells, Circulating

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Study Results

No Results Posted as of Jan 12, 2016