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RESEARCH PROTOCOL
Year : 2021  |  Volume : 10  |  Issue : 5  |  Page : 335-343

The EUS molecular evaluation of pancreatic cancer: A prospective multicenter cohort trial


1 Centre for Innate Immunity and Infectious Diseases, Hudson Institute of Medical Research; Department of Molecular Translational Science, Faculty of Medicine, Nursing and Health Sciences, Monash University; Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia
2 Department of Surgery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia
3 Department of Genetics and Molecular Pathology, Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia
4 Department of Gastroenterology, Monash Medical Centre, Monash Health, Clayton, Victoria, Australia
5 Department of Gastroenterology, Hepatology and Nutrition, UT MD Anderson Cancer Centre, Houston, TX, USA
6 Department of Precision Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton; Department of Pathology, Epidemiology Laboratory, The University of Melbourne, Parkville, Victoria, Australia
7 Department of Gastroenterology, Austin Health, Heidelberg; Department of Medicine, The University of Melbourne (Austin Health), Melbourne, Victoria, Australia
8 Department of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia
9 Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Victoria, Australia
10 Department of Gastroenterology, St Vincent's Hospital, Melbourne, Victoria, Australia
11 Department of Surgery, Alfred Health, Melbourne, Victoria, Australia
12 Department of Oncology, Faculty of Medicine, Nursing and Health Sciences and School of Clinical Sciences, Monash University, Clayton, Victoria, Australia
13 Department of Oncology, Northern Health, Epping, Victoria; Peter MacCallum Cancer Centre, Parkville, VIC, Australia
14 Department of Gastroenterology, Royal Melbourne Hospital; School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia
15 Centre for Innate Immunity and Infectious Diseases, Hudson Institute of Medical Research; Department of Molecular Translational Science, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia
16 Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia

Correspondence Address:
Daniel Croagh
Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria 3800
Australia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/EUS-D-20-00230

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Background and Objectives: Patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (A-PDAC) are not candidates for surgical resection and are often offered palliative chemotherapy. The ready availability of a safe and effective tumor sampling technique to provide material for both diagnosis and comprehensive genetic profiling is critical for informing precision medicine in A-PDAC, thus potentially increasing survival. The aim of this study is to examine the feasibility and benefits of routine comprehensive genomic profiling (CGP) of A-PDAC using EUS-FNA material. Methods: This is a prospective cohort study to test the clinical utility of fresh frozen or archival EUS-FNA samples in providing genetic material for CGP. The results of the CGP will be reviewed at a molecular tumor board. The proportion of participants that have a change in their treatment recommendations based on their individual genomic profiling will be assessed. Correlations between CGP and stage, prognosis, response to treatment and overall survival will also be investigated. This study will open to recruitment in 2020, with a target accrual of 150 A-PDAC patients within 36 months, with a 2-year follow-up. It is expected that the majority of participants will be those who have already consented for their tissue to be biobanked in the Victorian Pancreatic Cancer Biobank at the time of diagnostic EUS-FNA. Patients without archival or biobanked material that is suitable for CGP may be offered a EUS-FNA procedure for the purposes of obtaining fresh frozen material. Discussion: This trial is expected to provide crucial data regarding the feasibility of routine CGP of A-PDAC using EUS-FNA material. It will also provide important information about the impact of this methodology on patients' survival.


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