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As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
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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.
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:
Control patients: Target is 50, with acute pancreatitis admitted to hospital for observation/treatment.
Blood samples will be taken at the following time points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Unresectable or metastatic PDAC patients who will receive standard treatment of CT +/- radiotherapy | ||
| A | Resectable PDAC patients who will receive standard treatment of CT +/- radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to disease recurrence | Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence | Blood samples analysed up to 2 year follow up, estimated 4 years in total |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of progression free survival | To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival | Blood samples analysed up to 2 year follow up, estimated 4 years in total |
| Accuracy, sensitivity, specificity and concordance index |
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Inclusion Criteria:
Cohort A: resectable cancer OR Cohort B.1: unresectable locally advanced cancer OR Cohort B.2: metastatic cancer
Exclusion Criteria:
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All patients on this study must have pancreatic ductal adenocarcinoma.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beacon Hospital | Dublin | Dublin 18 | Ireland | |||
| Our Lady of Lourdes Hospital Drogheda |
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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 |
| For the duration of study, expected 4 years |
| Drogheda |
| Louth |
| Ireland |
| Bon Secours | Cork | Ireland |
| Beaumont Hospital | Dublin | Ireland |
| St Vincent's Hospital | Dublin | Ireland |
| Galway University Hospital | Galway | Ireland |
| Midwestern Regional Hospital | Limerick | Ireland |
| Adelaide Meath National Childrens Hospital | Tallaght | 24 | Ireland |
| Waterford Regional Hospital | Waterford | Ireland |