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 : September 17, 2021
|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|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||December 2022|
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.
- 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
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
|Contact: Karlyn Pierson, MAN, RNfirstname.lastname@example.org|
|Contact: Bettie Lectenberg, MBAemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Karlyn E Pierson, RN 507-538-1960 firstname.lastname@example.org|
|Principal Investigator: Dennis A Wigle, MD, PhD|
|Principal Investigator:||Dennis Wigle, MD, PhD||Mayo Clinic|