The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring

January 5, 2016 updated by: GenoSaber
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence.
Time Frame: 3 years
3 years
Liconography using conventional CT examination results.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenoSaber

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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