Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 169
- Locations
- 9
- Primary Endpoint
- Time to disease recurrence
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time to disease recurrence
Time Frame: 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 Outcomes
- Rate of progression free survival(Blood samples analysed up to 2 year follow up, estimated 4 years in total)
- Accuracy, sensitivity, specificity and concordance index(For the duration of study, expected 4 years)