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Clinical Trials/NCT02410603
NCT02410603
Completed
Not Applicable

Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer

Mayo Clinic1 site in 1 country64 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Mayo Clinic
Enrollment
64
Locations
1
Primary Endpoint
The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).

Detailed Description

Our plan is to collect blood from patients with advanced stage lung cancer who are scheduled to undergo systemic therapy. In this study we will utilize a novel technology for circulating tumor DNA detection in order to evaluate their presence in patients with lung cancer by comparing blood samples at six time points. We will obtain baseline blood and then collect blood at five time points during the course of the patient's chemotherapy treatments and at the end of treatment. These same blood collections will be used for the detection of soluble immune markers and evaluation of PBMCs.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
January 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aaron S. Mansfield, M.D.

PI

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Advanced (non-resectable) malignancy in the thorax
  • Age \>18 years old
  • Willing and able to provide consent
  • No prior history of neoadjuvant therapy

Exclusion Criteria

  • Age \<18 years old
  • Unable to provide consent
  • Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)

Outcomes

Primary Outcomes

The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.

Time Frame: 1 year

Study Sites (1)

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