Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

NCT02549638 | Terminated

• 1 other identifier: 15-000548
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

DNA Extraction GENETIC

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.

Tissue Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mayo Clinic Thoracic Surgery Patients

You may qualify if:

• 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

You may not qualify if:

• unable to provide consent
• pregnant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dennis Wigle, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 15, 2015
• Study Start: April 8, 2015
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)