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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02370303
Enrollment
23
Registered
2015-02-24
Start date
2014-08-31
Completion date
2016-07-09
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma, Cancer of Lung, Cancer of the Lung, Carcinoma, Non-small-cell Lung, Lung Cancer, Lung Neoplasms, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Squamous Cell Carcinoma

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.

Interventions

None listed

Sponsors

Clearbridge Biomedics
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Concordance of mutations detected by either method.Within 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026