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临床试验/NCT02549638
NCT02549638终止不适用

Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
22
试验地点
1
主要终点
Number and types of recurrent genomic alterations evaluated by a custom targeted sequencing panel.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • unable to provide consent

结局指标

主要结局

Number and types of recurrent genomic alterations evaluated by a custom targeted sequencing panel.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis Wigle

PI

Mayo Clinic

研究点 (1)

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