Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total DNA Yield of Adenocarcinoma
研究概览
简要总结
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
详细描述
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion.
- •International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,
- •Medically stable to undergo sedation for EUS.
- •Signed informed consent
排除标准
- •Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
- •Pregnant patients
结局指标
主要结局
Total DNA Yield of Adenocarcinoma
时间窗: Baseline
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
次要结局
- Percentage of Tumor Cellularity(Baseline)
- Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis(Baseline)
- Concentration of DNA Yield of Adenocarcinoma(Baseline)
- Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation(Baseline)
- Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation(Baseline)
- Core Tissue Length(Baseline)
研究者
Michael Wallace
M.D, MPH, Professor of Medicine
Mayo Clinic