Expired Study
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Rochester, Minnesota 55905


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

14-003962


NCT ID:

NCT02370303


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

23


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dennis Wigle, MD, PhD
Principal Investigator
Mayo Clinic

Study Dates

Start Date:August 2014
Completion Date:July 9, 2016
Completion Type:Actual
Primary Completion Date:July 9, 2016
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 20, 2018
First Received Date:February 17, 2015

Study Outcomes

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

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Clearbridge Biomedics

Samples and Retentions

Sample Retention:Samples With DNA
Description: Preoperative blood sample, tumor tissue from lung resection, postoperative blood 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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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