None listed
Conditions
Brief summary
The National Comprehensive Cancer Network now recommends molecular screening for all patients with advanced pancreatic duct adenocarcinoma (PDAC) to enable patients to benefit from these strategies. The predominant method of obtaining tissue to establish the diagnosis of PDAC is a specific ultrasound guided fine needle biopsy. This study aims to test the use of additional fluids that are collected as part of the tissue biopsy to determine whether the DNA extracted from these fluids is enough to create a genetic profile of the patient's pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with pancreatic adenocarcinoma that is locally advanced or metastatic (has spread to other body systems) and you have undergone an endoscopic ultrasound biopsy to establish the diagnosis of pancreatic cancer. Study details All participants who choose to enrol in this study will consent to having the fluids previously collected during their ultrasound biopsy assessed. Participants will not be asked to provide additional blood or tissue samples as part of this study. Each sample will be assessed to determine whether there is sufficient genetic material present to create a profile of the patient's specific cancer. For participants where a genetic profile can be generated, this information will be sent to a board of cancer experts who will review the profile against a list of new and existing cancer treatments. If a suitable treatment is identified, the participant will be informed within 1 month following review of their comprehensive molecular profiling, and they will then be able to start on the treatment if they agree to. It is hoped this research will demonstrate that it is possible to create a specific cancer profile for patients with pancreatic cancer from previously collected samples, without the need for additional biopsies. It is also hoped that this research may enable identification of personalised treatment options for pancreatic cancer patients, which may improve their quality of life and survival.
Interventions
This is a prospective cohort study. Participants with advanced pancreatic cancer who have undergone endoscopic ultrasound fine needle biopsy will be eligible to enrol. The supernatant fluid that is left over after processing the endoscopic ultrasound fine needle biopsy (which is normally discarded) will be collected for DNA and RNA extraction as part of this study. If there is sufficient genetic material, the patients will be referred to the MoST study for comprehensive molecular profiling and r
This is a prospective cohort study. Participants with advanced pancreatic cancer who have undergone endoscopic ultrasound fine needle biopsy will be eligible to enrol. The supernatant fluid that is left over after processing the endoscopic ultrasound fine needle biopsy (which is normally discarded) will be collected for DNA and RNA extraction as part of this study. If there is sufficient genetic material, the patients will be referred to the MoST study for comprehensive molecular profiling and review at a molecular tumour board which will be conducted according to the standard protocols for this study (ACTRN12616000908437). Thus, participants will need consent to participate in the MoST study for comprehensive molecular profiling. Entry into MoST substudies and long-term follow up and will be conducted according to the usual protocols of the MoST study.
Sponsors
Monash Health Department of Upper GI Surgery
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females with cytologically proven adenocarcinoma of the pancreas obtained by EUS-FNA. In those with ‘suspicious’ cytology, the diagnosis of pancreatic adenocarcinoma will be made in conjunction with supporting biochemical and radiological data 2. Metastatic, locally advanced (based on the NCCN guidelines version 2, 2017 criteria) or recurrent disease 3. EUS-FNA supernatant available for DNA/RNA extraction. 4. Study participants must be at least 18 years of age at time of screening 5. ECOG Performance Status 0-2 6. Suitability for chemotherapy 7. Able to give signed informed consent 8. Life expectancy of at least 3 months from the time of screening as judged by screening investigator. 9. Willingness to participate in the MoST program (ACTRN12616000908437)
Exclusion criteria
1. Patients considered to have operable or borderline resectable pancreatic cancer 2. Patients with Neuroendocrine pancreatic cancers 3. Evidence of systemic disease (cardiovascular, respiratory, renal, hepatic, etc.) that would preclude chemotherapy. 4. Serious medical or psychiatric conditions that might compromise protocol-based management as judged by investigator
Outcome results
None listed