TerminatedNCT02050997Updated Jul 8, 2025

Plasma Biomarkers P-DAC, V1

An observational study in Pancreatic Ductal Adenocarcinoma, sponsored by Cancer Trials Ireland. Terminated at 9 sites in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Cancer Trials Ireland · Observational

Why this study was terminated

As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 169
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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

Conditions studied

Pancreatic Ductal Adenocarcinoma

In context

Lead sponsor

Cancer Trials Ireland is the lead sponsor of 69 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

All patients on this study must have pancreatic ductal adenocarcinoma.

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 169 participants (actual)
Patient registry: No

Groups and cohorts

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 researchers measure

Primary outcomes

Time to disease recurrence
Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence
Time frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total

Secondary outcomes

Rate of progression free survival
To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival
Time frame: 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
Time frame: For the duration of study, expected 4 years

Study locations

9 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02050997
Lead sponsor: Cancer Trials Ireland
Responsible party: Sponsor
First posted: Jan 31, 2014
Start date: May 26, 2014
Primary completion: Dec 2021
Completion: Dec 2021
Last update: Jul 8, 2025

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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