Plasma Biomarkers PDAC, V1
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.
Pancreatic Ductal Adenocarcinoma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)|
- Time to disease recurrence [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ] [ Designated as safety issue: No ]Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence
- Rate of progression free survival [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ] [ Designated as safety issue: No ]To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival
- Accuracy, sensitivity, specificity and concordance index [ Time Frame: For the duration of study, expected 4 years ] [ Designated as safety issue: No ]Aim to validate a panel of predicitive 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
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Unresectable or metastatic PDAC patients who will receive standard treatment of CT +/- radiotherapy
Resectable PDAC patients who will receive standard treatment of CT +/- radiotherapy
This study will involve two cohort groups, all patients involved will have PDAC.
Cohort A will involve resectable PDAC patients who will receive standard treatment of CT (with/without radiotherapy).
Cohort B will comprise of unresectable advanced PDAC patients and metastatic PDAC patients, both of whom will receive standard treatment of CT (with/without radiotherapy).
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
|Cork University Hospital||Active, not recruiting|
|Contact: Contact Person 01-8377547|
|Principal Investigator: Liam Grogan, Prof|
|Galway University Hospital||Active, not recruiting|
|Midwestern Regional Hospital||Active, not recruiting|
|Adelaide Meath National Childrens Hospital||Recruiting|
|Tallaght, Ireland, 24|
|Contact: Contact Person 01-4142000|
|Principal Investigator: MinYuen Teo, Dr|
|Waterford Regional Hospital||Recruiting|
|Contact: Contact Person 051-848000|
|Principal Investigator: Anne Horgan, Dr|