Official Title
Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma
Brief Title
Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma
Protocol ID
NCT02549638
Lead Sponsor
Mayo Clinic
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.
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 Period
-
Enrollment Count
22 participants
Eligibility 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
Filters
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
TERMINATED
ADULT
OLDER_ADULT