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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 : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

Tracking Information
First Submitted Date September 10, 2015
First Posted Date September 15, 2015
Last Update Posted Date October 18, 2018
Study Start Date August 2015
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02549638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma
Official Title Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples
Sampling Method Non-Probability Sample
Study Population Mayo Clinic Thoracic Surgery Patients
Condition
  • 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
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.
Study Groups/Cohorts 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.
Intervention: Genetic: DNA Extraction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 11, 2015)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Karlyn Pierson, MAN, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lectenberg, MBA 507-266-4819 lechtenberg.bettie@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02549638
Other Study ID Numbers 15-000548
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dennis Wigle, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2018