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NCT02370303 Clinical Trial

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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02370303
Other study ID # 14-003962
Secondary ID
Status Completed
Phase
First received February 17, 2015
Last updated March 20, 2018
Start date August 2014
Est. completion date July 9, 2016

Study information
Verified date March 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date July 9, 2016
Est. primary completion date July 9, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Clearbridge Biomedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number and types of mutations in the primary tumor. Within 1 year
Primary Number and type of mutations detectable in the matched circulating tumor cell samples. Within 1 year
Secondary Concordance of mutations detected by either method. Within 1 year
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