None listed
Conditions
Brief summary
Pancreatic cancer is a devastating disease that is set to become the 2nd leading cause of cancer-related deaths worldwide by 2020. Over 80% of pancreatic cancer patients are diagnosed with unresectable locally advanced or metastatic disease. Through data collection and correlation with analyses of archival tumour specimens and blood collections, this trial aims to identify and validate novel diagnostic and monitoring methods; novel predictive and prognostic biomarkers and to use these to inform studies of novel therapeutic opportunities that will improve the management of pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with pancreatic ductal adenocarcinoma (PDAC). Study details This protocol aims to enrol at least 500 consecutive eligible patients over 10 years. Enrolled patients will undergo collection of clinical data and archival tumour specimens. Where applicable, patients will also undergo collection of blood and/ or urine at several time points. Once a sufficient cohort has been enrolled, selected molecular analyses will be conducted on each specimen, thus, allowing for batching of specimens. Enrolled patients will undergo collection of clinical data and archival or fresh tumour specimens as part of routine clinical management, with all patients will be treated as per standard of care. When applicable, archival tissue samples from the primary pancreatic cancer, matched normal pancreas tissue and/or resected metastases will be obtained, upon enrolment. to study. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures. Patients that consent to the “liquid biopsy” (blood and urine collection) sub-study will undergo collection of blood/plasma and urine at the beginning and during each systemic therapy. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions: 1. Before and after surgical removal of pancreatic cancer (if applicable) 2. Before and after any chemotherapy regimen (if applicable) 3. Every 6 months while you are on active surveillance (if applicable) Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Interventions
Potential subjects with pancreatic cancer may be identified at pre-admission or outpatient clinic by a clinician or VCB research coordinator, and if consent is obtained tissue, blood and/or urine sample will be collected. All patients will be treated as per standard of care. The only procedure beyond standard of care is the collection of tissue, blood and/or urine samples.
Blood and/or urine samples will be collected at the time of other standard-care assessments (such as CEA) to minimise/elim
Potential subjects with pancreatic cancer may be identified at pre-admission or outpatient clinic by a clinician or VCB research coordinator, and if consent is obtained tissue, blood and/or urine sample will be collected. All patients will be treated as per standard of care. The only procedure beyond standard of care is the collection of tissue, blood and/or urine samples. Blood and/or urine samples will be collected at the time of other standard-care assessments (such as CEA) to minimise/eliminate the need for additional venipunctures. Blood (upto 60 ml) and urine (upto 60 ml) will be collected for research purposes on the following occasions: 1. Before and after surgical removal of pancreatic cancer (if applicable) 2. Before and after any chemotherapy regimen (if applicable) 3. Every 6 months while you are on active surveillance (if applicable) Archival tissue specimens will be requested for each patient after enrolment. Where possible, current biopsy specimens (fresh tissue) will be collected by either Victorian Cancer Biobank or local pathology laboratories at the time of standard of care procedures, Follow up will occur until the end of active surveillance, death or 5 years post enrolment, whichever occurs first.
Sponsors
The Walter and Eliza Hall Institute of Medical Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female 2. At least 18 years of age 3. Patients with histologically or cytologically confirmed pancreatic cancer. 4. Able to provide archival tumour specimen for molecular analysis 5. Accessible for follow up and data collection 6. Able and willing to provide informed consent for any blood and urine collection above standard of care. Able to provide written, voluntary and informed consent for blood and/or urine collection
Exclusion criteria
1. No archival tissue specimen available for molecular analysis 2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the tissue collection protocol 3. Females who are pregnant
Outcome results
None listed