NCT02647164

Brief Summary

The purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2\~7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36 months after the surgery.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ 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

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Last Updated

January 6, 2016

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

December 28, 2015

Last Update Submit

January 5, 2016

Conditions

Non-small-cell Lung Carcinoma

Keywords

Non-small-cell lung carcinomaCirculating tumor cells

Outcome Measures

Primary Outcomes (1)

  • Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.

    3 years

Secondary Outcomes (2)

  • carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence.

    3 years

  • Liconography using conventional CT examination results.

    3 years

Eligibility Criteria

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

Patients with NSCLC(stage Ⅰ/Ⅱ/ⅢA), who will receive operation.

You may qualify if:

  • Age 18-80 years old
  • Patients with histologically documented (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
  • Patients will undergo surgery.
  • Patients with preoperative CTCs ≥8.5 Units / 3 ml
  • Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Patients with histologically documented not (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
  • After the operation review, patients' result of CTC, CT and tumor markers is incomplete at the same point.
  • The blood sample isn't collected in predetermined time.
  • The blood samples appear hemolysis.
  • The blood sample isn't enough.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Last Updated

January 6, 2016

Record last verified: 2015-09