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 28, 2022
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Condition or disease | Intervention/treatment |
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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 |
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 2023 |
Estimated Study Completion Date : | August 2023 |

Group/Cohort | Intervention/treatment |
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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.
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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

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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 |
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

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, RN | 507-538-1960 | pierson.karlyn@mayo.edu | |
Contact: Bettie Lectenberg, MBA | 507-266-4819 | lechtenberg.bettie@mayo.edu |
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 |
Principal Investigator: | Dennis Wigle, MD, PhD | Mayo Clinic |
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: | September 28, 2022 |
Last Verified: | September 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |