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

A Pilot 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.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma; Lung Neoplasms; Lung Cancer; Neoplasms, Lung; Pulmonary Neoplasms; Squamous Cell Carcinoma; Neoplasms, Pulmonary; Pulmonary Cancer; Cancer of Lung; Cancer of the Lung; Carcinoma, Non-small-cell Lung

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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a stage IB or above non-small cell lung cancer or metastatic cancer undergoing lung surgery at the Mayo Clinic in Rochester, MN.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and types of mutations in the primary tumor.	Within 1 year
Number and type of mutations detectable in the matched circulating tumor cell samples.	Within 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Concordance of mutations detected by either method.	Within 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Clearbridge Biomedics

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 9, 2016
• Study Completion (Actual): July 9, 2016

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Neoplastic Cells, Circulating
• Other Study ID Numbers: 14-003962