Pancreatic Cancer Cancer Pancreatic Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients (age >16 years) 2. With either: 2.1. Presence of a hypodense pancreatic mass highly suspicious of primary pancreatic cancer with or without distant metastasis as assessed by a Pancreatic Multi-Disciplinary Team (MDT) or 2.2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants 3. Patient is willing and able to undergo tumour biopsy aimed at obtaining sufficient tissue for molecular profiling 4. Patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation 5. Signed informed consent for screening research tumour biopsy (Consent 1) 6. Signed informed consent for Precision-Panc Master Protocol molecular profiling (Consent 2)
Exclusion criteria
Exclusion criteria: There is no participant exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish a mechanism and framework to recruit and screen patients with pancreatic cancer to perform molecular profiling, evaluation of circulating biomarkers and allow enrolment to Precision Panc PRIMUS studies. This will be measured by the number of patients screened and registered to the study and the number of patients where a molecular profile is obtained. The number of patients registered to Precision Panc who then go onto a PRIMUS study will also be measured | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the overall survival (OS) in patients enrolled in Precision-Panc and relate this to molecular profile information 2. To assess the safety of obtaining tumour biopsies suitable for molecular profiling within a standard patient treatment pathway 3. To establish a central repository of molecular profiles with accompanying phenotypic data and accompanying biospecimens for further translational research 4. To establish a dynamic platform for evaluation of circulating biomarkers to subsequently inform design of subsequent clinical studies | — |
Countries
England, Northern Ireland, Scotland, United Kingdom