NCT02653859

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

January 12, 2016

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

January 3, 2016

Last Update Submit

January 10, 2016

Conditions

Solitary Pulmonary Nodule

Keywords

CTCPCR

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The concentration of the tumor marker of pro gastrin releasing peptide(Pro-GRP) will be detected in baseline by Electrochemical luminescence.

    1 months

  • The concentration of the tumor marker of neurone specific enolase(NSE) will be detected in baseline by Electrochemical luminescence.

    1 months

  • The concentration of the tumor marker of carcinoembryonic antigen(CEA) will be detected in baseline by Electrochemical luminescence.

    1 months

  • The concentration of the tumor marker of cytokeratin 19 fragments(CYFRA211) will be detected in baseline by Electrochemical luminescence.

    1 months

  • The concentration of the tumor marker of squamous cell carcinoma antigen(SCC) will be detected in baseline by Electrochemical luminescence.

    1 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

New Solitary Pulmonary Nodule

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 12, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Last Updated

January 12, 2016

Record last verified: 2015-10