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Clinical Trials/NCT02370303
NCT02370303
Completed
Not Applicable

A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System

Mayo Clinic1 site in 1 country23 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Mayo Clinic
Enrollment
23
Locations
1
Primary Endpoint
Number and types of mutations in the primary tumor.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.

Detailed Description

The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
July 9, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dennis Wigle

PI

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Stage IB and above non-small cell lung cancer or metastatic lung cancer
  • Age \>18 years old
  • Willing and able to consent to study
  • No prior history of neoadjuvant therapy.

Exclusion Criteria

  • Age \<18 years old
  • Unable to provide consent

Outcomes

Primary Outcomes

Number and types of mutations in the primary tumor.

Time Frame: Within 1 year

Number and type of mutations detectable in the matched circulating tumor cell samples.

Time Frame: Within 1 year

Secondary Outcomes

  • Concordance of mutations detected by either method.(Within 1 year)

Study Sites (1)

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