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

NCT ID: NCT02370303

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-07-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clearbridge Biomedics

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Dennis Wigle

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis Wigle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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14-003962

Identifier Type: -

Identifier Source: org_study_id

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