Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Total DNA Yield of Adenocarcinoma
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Michael Wallace
M.D, MPH, Professor of Medicine
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
- •Pregnant patients
Outcomes
Primary Outcomes
Total DNA Yield of Adenocarcinoma
Time Frame: Baseline
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
Secondary Outcomes
- 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)