RecruitingACTRN12620000762954

Molecular Evaluation of Pancreatic Cancer

Endoscopic Ultrasound Molecular Evaluation of Pancreatic Cancer Trial

Sponsor

Dr Daniel Croagh

Enrollment

150 participants

Start Date

May 27, 2020

Study Type

Observational

Conditions

Unresectable or metastatic pancreatic ductal adenocarcinoma or recurrent disease

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Pancreatic cancer is one of the most difficult cancers to treat, with very few patients surviving long-term. Most cases are diagnosed at an advanced stage when surgery is no longer possible. Understanding the specific genetic mutations within a tumour can help doctors select targeted therapies that are more likely to work for an individual patient — a concept called precision medicine. This study is examining whether comprehensive genetic testing (genomic profiling) of tumour tissue collected during a diagnostic biopsy procedure (endoscopic ultrasound-guided biopsy, or EUS-FNA) is feasible in routine clinical practice for patients with advanced pancreatic cancer. Results are shared with the treating oncologist and could open the door to clinical trials or targeted therapies. Patients are followed for up to three years. You may be eligible if you are 18 or older and have been diagnosed with locally advanced (inoperable) or metastatic pancreatic cancer, with tumour tissue available for analysis, and are well enough to receive chemotherapy. People with operable or borderline resectable pancreatic cancer, neuroendocrine pancreatic cancers, or serious medical or psychiatric conditions that would interfere with treatment are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

The Alfred - Melbourne

VIC, Australia

Cabrini Hospital - Malvern - Malvern

VIC, Australia

Cabrini Hospital - Prahran - Prahran East

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Peninsula Oncology Centre - Frankston

VIC, Australia

Epworth Eastern Hospital - Box Hill

VIC, Australia

North Eastern Community Hospital Inc - Campbelltown

VIC, Australia

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ACTRN12620000762954