Pancreatic Ductal AdenocarcinomaNCT02050997
Plasma Biomarkers P-DAC, V1
An observational study of Pancreatic Ductal Adenocarcinoma, run by Cancer Trials Ireland at 9 sites in Ireland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- How many people
- 169 participants
- Where
- 9 sitesIreland
- Study dates
- 26 May 2014to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients on this study must have pancreatic ductal adenocarcinoma.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Ireland9 sites
Bon Secours
Cork
Our Lady of Lourdes Hospital Drogheda
Drogheda, Louth
Beacon Hospital
Dublin, Dublin 18
Beaumont Hospital
Dublin
St Vincent's Hospital
Dublin
Galway University Hospital
Galway
Midwestern Regional Hospital
Limerick
Adelaide Meath National Childrens Hospital
Tallaght, 24
Waterford Regional Hospital
Waterford
About this study
Official title: 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.
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
- Pancreatic Ductal Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Time to disease recurrence
Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence
Measured: Blood samples analysed up to 2 year follow up, estimated 4 years in total
Secondary outcomes (2)
Rate of progression free survival
To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival
Measured: 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
Measured: For the duration of study, expected 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study start26 May 2014
- Primary completionDec 2021
- Study completionDec 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050997
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 12-31
- Status last verified
- Jul 2025
- First submitted
- 24 Jan 2014
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)
- ClinicalTrials.gov ID
- NCT02050997
- Acronym / sponsor ID
- CTRIAL-IE (ICORG) 12-31
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 26 May 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients on this study must have pancreatic ductal adenocarcinoma.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Rate of 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
Time frame: For the duration of study, expected 4 years
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Cancer Trials Ireland at 9 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease recurrence (time frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.