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Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02549638
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : October 5, 2023
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

Study Description
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Brief Summary:
The study will utilize both retrospective and prospective data collection from patients that already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria.

Condition or disease Intervention/treatment
Carcinoma, Squamous Cell Carcinoma, Squamous Squamous Cell Carcinoma Lung Neoplasms Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms Genetic: DNA Extraction

Detailed Description:
The study will utilize both retrospective and prospective data collection from patients that have already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria. If a patient has already had a bronchoscopy and has consented to have samples stored for research at the Mayo Clinic Rochester we will access them for the research study if available. Otherwise, if the patient has already had surgery and tissue has not been stored for research the investigators will consent patients to use their clinical specimens for the research study. The investigators will then extract DNA from tissue sections and blood and use a custom targeted sequencing panel of 23 cancer driver genes with significant mutations in squamous cell carcinoma that they have developed to find the prognostic biomarkers. The DNA will be used in a PCR reaction to generate amplicons for library preparation using Illumina Nextera XT library preparation protocol and targeted sequencing on the Illumina Hiseq sequencer. The reads will be aligned to the HG19 using BWA aligner and variant detection performed with Agilent SureCall and GATK analytic tools.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma
Study Start Date : August 2015
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Tissue Collection
We plan to prospectively collect 5 bronchoscopic biopsies, 3ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria. If a patient has already had a bronchoscopy and has samples available that were previously collected and stored for research at the Mayo Clinic we will use those samples.
 Genetic: DNA Extraction
We will then extract DNA from tissue sections and blood and use a custom targeted sequencing panel of 23 cancer driver genes with significant mutations in squamous cell carcinoma that we have developed to find the prognostic biomarkers. The DNA will be used in a PCR reaction to generate amplicons for library preparation using Illumina Nextera XT library preparation protocol and targeted sequencing on the Illumina Hiseq sequencer. The reads will be aligned to the HG19 using BWA aligner and variant detection performed with Agilent SureCall and GATK analytic tools.


Outcome Measures
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Primary Outcome Measures :
  1. Number and types of recurrent genomic alterations evaluated by a custom targeted sequencing panel. [ Time Frame: 2 years ]
    The aim of this study is to identify and characterized recurrent genomic alteration found in invasive squamous cell carcinoma that are present in the precursor airway epithelial tissues but absent in normal tissues examined from samples taken during a lung procedure.


Biospecimen Retention:   Samples With DNA
5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples

Eligibility Criteria
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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
Mayo Clinic Thoracic Surgery Patients
Criteria

Inclusion Criteria:

  • known or suspected squamous cell carcinoma of the lung
  • able to provide consent
  • could have already had a bronchoscopy or surgical resection with tissue saved at the Mayo Clinic Rochester
  • will be undergoing a bronchoscopy and having a surgical resection at the Mayo Clinic Rochester

Exclusion Criteria:

  • unable to provide consent
  • pregnant
Contacts and Locations
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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): NCT02549638


Contacts
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Contact: Karlyn Pierson, MAN, RN 507-538-1960 pierson.karlyn@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karlyn E Pierson, RN    507-538-1960    pierson.karlyn@mayo.edu   
Principal Investigator: Dennis A Wigle, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
More Information
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Responsible Party: Dennis Wigle, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02549638    
Other Study ID Numbers: 15-000548
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: October 5, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms, Squamous Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases