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

July 19, 2021 updated by: Aaron S. Mansfield, M.D., Mayo Clinic
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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced stage cancer in the thorax who are scheduled to undergo systemic therapy at the Mayo Clinic in Rochester, MN.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Aaron Mansfield, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-000373

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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