Plasma Biomarkers P-DAC, V1

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

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Ductal Adenocarcinoma

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

• Study Type: Observational
• Enrollment (Actual): 169

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Bon Secours
  • Dublin, Ireland
    • Beaumont Hospital
  • Dublin, Ireland
    • St Vincent's Hospital
  • Galway, Ireland
    • Galway University Hospital
  • Limerick, Ireland
    • Midwestern Regional Hospital
  • Tallaght, Ireland, 24
    • Adelaide Meath National Childrens Hospital
  • Waterford, Ireland
    • Waterford Regional Hospital
  • Dublin 18
    • Dublin, Dublin 18, Ireland
      • Beacon Hospital
  • Louth
    • Drogheda, Louth, Ireland
      • Our Lady of Lourdes Hospital Drogheda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients on this study must have pancreatic ductal adenocarcinoma.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2014
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimated): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: CTRIAL-IE (ICORG) 12-31