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NCT02549638 Clinical Trial

Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

Lung Cancer Clinical Trial

Official title:
Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02549638
Other study ID # 15-000548
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2015
Est. completion date August 2024

Study information
Verified date October 2023
Source Mayo Clinic
Contact Karlyn Pierson, MAN, RN
Phone 507-538-1960
Email pierson.karlyn@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number and types of recurrent genomic alterations evaluated by a custom targeted sequencing panel. 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. 2 years
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