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

Completed

• Conditions: Lung Cancer; Neoplasms, Pulmonary; Adenocarcinoma; Squamous Cell Carcinoma; Lung Neoplasms; Cancer of the Lung; Neoplasms, Lung; Pulmonary Cancer; Pulmonary Neoplasms; Carcinoma, Non-small-cell Lung

• Registration Number: NCT02410603
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-07
• Study Start: 2016-12
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.	1 year

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States