Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
This is an exploratory, translational, non-interventional and multi-centre clinical study. The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy in PDAC.
Detailed description
This study will involve two cohort groups, all patients involved will have PDAC. Cohort A: Target is 80 resectable PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy Cohort B: * Cohort B1 = Target is 80 unresectable locally advanced PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy. * Cohort B2 = Target is metastatic PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy. Control patients: Target is 50, with acute pancreatitis admitted to hospital for observation/treatment. Blood samples will be taken at the following time points: * prior to resection, whenever feasible for cohort A * prior to CT, for both cohort A and B * during CT, for both cohort A and B * follow-up, approximately every 3 to 6 months for two years for cohort A
Interventions
None listed
Sponsors
Cancer Trials Ireland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years of age * Ability to give written informed consent * Histologically or cytologically-confirmed PDAC * Patients who will receive standard treatment of CT +/- radiotherapy and present with: Cohort A: resectable cancer OR Cohort B.1: unresectable locally advanced cancer OR Cohort B.2: metastatic cancer * Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2
Exclusion criteria
* Presence of medical or psychiatric conditions, which, in the opinion of the investigator, would potentially pose a risk to the patient in participating in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease recurrence | Blood samples analysed up to 2 year follow up, estimated 4 years in total | Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of progression free survival | Blood samples analysed up to 2 year follow up, estimated 4 years in total | To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival |
| Accuracy, sensitivity, specificity and concordance index | For the duration of study, expected 4 years | Aim to validate a panel of predictive plasma biomarkers proving its accuracy, sensitivity, specificity and to investigate their expression at tissue level gaining a further understanding of cancer and/or host related proteins in disease response and progression |
Countries
Ireland
Outcome results
None listed