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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02653859

Enrollment

Registered

2016-01-12

Start date

2016-01-31

Completion date

Unknown

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solitary Pulmonary Nodule

Keywords

CTC, PCR

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results