Plasma Biomarkers P-DAC, V1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02050997|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : January 9, 2020
|Condition or disease|
|Pancreatic Ductal Adenocarcinoma|
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 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
|Study Type :||Observational|
|Actual Enrollment :||169 participants|
|Official Title:||Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2021|
Unresectable or metastatic PDAC patients who will receive standard treatment of CT +/- radiotherapy
Resectable PDAC patients who will receive standard treatment of CT +/- radiotherapy
- 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
- Rate of progression free survival [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050997
|Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland|
|Our Lady of Lourdes Hospital Drogheda|
|Drogheda, Louth, Ireland|
|St Vincent's Hospital|
|Galway University Hospital|
|Midwestern Regional Hospital|
|Adelaide Meath National Childrens Hospital|
|Tallaght, Ireland, 24|
|Waterford Regional Hospital|