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Completed

NCT Number: NCT02370303

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

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.

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Key information

Conditions

Lung Cancer Adenocarcinoma Bronchial Neoplasms Cancer of Lung Cancer of the Lung Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Lung Neoplasms, Pulmonary Neoplasms, Squamous Cell Pulmonary Cancer Pulmonary Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number and types of mutations in the primary tumor.

    Time frame: Within 1 year

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

    Time frame: Within 1 year

Secondary outcomes

  1. Concordance of mutations detected by either method.

    Time frame: Within 1 year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Clearbridge Biomedics

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2015
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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