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NCT02410603 Clinical Trial

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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02410603
Other study ID # 15-000373
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2016
Est. completion date January 1, 2021

Study information
Verified date July 2021
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 explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples. 1 year
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