Plasma Biomarkers P-DAC, V1

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)

Conditions
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Pancreatic Ductal Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B<br>Unresectable or metastatic PDAC patients who will receive standard treatment of CT +/- radiotherapy | |
| A<br>Resectable PDAC patients who will receive standard treatment of CT +/- radiotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |