This trial is active, not recruiting.

Conditions lung cancer, lung neoplasms, cancer of lung, cancer of the lung, neoplasms, lung, neoplasms, pulmonary, pulmonary cancer, pulmonary neoplasms, carcinoma, non-small-cell lung, adenocarcinoma, squamous cell carcinoma
Sponsor Mayo Clinic
Collaborator Clearbridge Biomedics
Start date August 2014
End date December 2017
Trial size 40 participants
Trial identifier NCT02370303, 14-003962


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

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.
time frame: Within 1 year

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
Principal investigator Dennis Wigle, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Mayo Clinic.