Molecular Evaluation of Pancreatic Cancer
Endoscopic Ultrasound Molecular Evaluation of Pancreatic Cancer Trial
Dr Daniel Croagh
150 participants
May 27, 2020
Observational
Conditions
Summary
The aim of this study is to examine the feasibility and potential benefits of routine comprehensive genomic profiling of advanced inoperable pancreatic cancer using fresh endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) material Who is it for? You may be eligible to join this study if you are male or female aged 18 years or above who is diagnosed with locally advanced (unresectable) or metastatic biopsy-proven pancreatic ductal adenocarcinoma (PDAC). Study details Following diagnostic biopsy (EUS-FNA), verification of eligibility for this study and informed consent, participants will enter the study. Patients may have a further EUS-FNA for the purpose of obtaining fresh frozen tissue if the extracted genetic material is insufficient for detailed analysis. Comprehensive genomic profiling will be performed on biobanked or archival material from the EUS-FNA. The results from this analysis will be reviewed and relayed to the participants treating oncologist. In case of a positive germline mutation, a referral for genetic counselling will be made. Patients will be followed up in the Upper Gastrointestinal Cancer Registry at 12, 24 and 36 months to be assessed for the uptake of targeted therapies and overall survival. Availability of a reasonably safe and effective tumour sampling technique to provide material for both diagnosis and comprehensive genomic profiling can pave way for the development of precision medicine, thus increasing survival.
Eligibility
Inclusion Criteria7
- Adults, age 18 years or over, male or female
- Locally advanced (unresectable) or metastatic biopsy-proven pancreatic ductal adenocarcinoma (PDAC) based on the NCCN guidelines version 2, 2017 criteria or recurrent disease
- Tumour tissue available for DNA/RNA extraction
- ECOG Performance Status 0-2
- Suitability for chemotherapy
- Provision of informed consent for participation in the study
- Life expectancy of at least 3 months from the time of screening as judged by screening investigator.
Exclusion Criteria4
- Operable or borderline resectable pancreatic cancer
- Neuroendocrine pancreatic cancers
- Evidence of systemic disease (cardiovascular, respiratory, renal, hepatic, etc.) that would preclude chemotherapy.
- Serious medical or psychiatric conditions that might compromise protocol-based management as judged by investigator
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Interventions
Following diagnostic biopsy (EUS-FNA), verification of eligibility for this study and informed consent, participants will enter the study. Patients may have a further EUS-FNA for the purpose of obtaining fresh frozen tissue if the extracted genetic material is insufficient for detailed analysis. Comprehensive genomic profiling will be performed on biobanked or archival material from the EUS-FNA. The results from this analysis will be reviewed and relayed to the participants treating oncologist. In case of a positive germline mutation, a referral for genetic counseling will be made. Patients will be followed up in the Upper Gastrointestinal Cancer Registry at 12, 24 and 36 months to be assessed for uptake of targeted therapies and overall survival. In this study, we will also assess the sensitivity and specificity of a previously established molecular diagnosis of PDAC by statistical analysis of the results obtained from the current and previous studies. We have already developed a genetic diagnostic approach for PDAC based on RNA sequencing (unpublished data). This diagnostic signature was subjected to validation using a smaller panel of genes on a NanoString platform (unpublished data). We will assess the utility of this diagnostic signature in confirming the presence of the PDAC tissue used for comprehensive genomic profiling.
Locations(10)
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ACTRN12620000762954