Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma
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| ClinicalTrials.gov Identifier: NCT02549638 |
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Recruitment Status :
Recruiting
First Posted : September 15, 2015
Last Update Posted : September 28, 2022
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Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic
| Tracking Information | |||||||||
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| First Submitted Date | September 10, 2015 | ||||||||
| First Posted Date | September 15, 2015 | ||||||||
| Last Update Posted Date | September 28, 2022 | ||||||||
| Study Start Date | August 2015 | ||||||||
| Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| 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 |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Mayo Clinic Thoracic Surgery Patients | ||||||||
| Condition |
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| 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.
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| 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
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 2023 | ||||||||
| Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Dennis Wigle, Mayo Clinic | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Mayo Clinic | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Mayo Clinic | ||||||||
| Verification Date | September 2022 | ||||||||