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

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ClinicalTrials.gov Identifier: NCT02410603
Recruitment Status : Recruiting
First Posted : April 7, 2015
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Aaron S. Mansfield, M.D., 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).

Condition or disease
Lung Cancer Lung Neoplasms Cancer of Lung Cancer of the Lung Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Carcinoma, Non-small-cell Lung Adenocarcinoma Squamous Cell Carcinoma

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer
Study Start Date : December 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine





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

Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410603


Contacts
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Contact: Karlyn Pierson, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg, MBA 507-266-4819 lechtenberg.bettie@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karlyn Pierson, RN    507-538-1960    pierson.karlyn@mayo.edu   
Principal Investigator: Aaron Mansfield, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Aaron Mansfield, MD Mayo Clinic

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Responsible Party: Aaron S. Mansfield, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02410603     History of Changes
Other Study ID Numbers: 15-000373
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aaron S. Mansfield, M.D., Mayo Clinic:
Chemotherapy

Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms