Clinical trial NCT02050997: Plasma Biomarkers P-DAC, V1
Official title: Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2014-01-31
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients on this study must have pancreatic ductal adenocarcinoma.

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Time to disease recurrence
timeFrame: Blood samples analysed up to 2 year follow up, estimated 4 years in total
Secondary outcomes:
measure: Rate of progression free survival
timeFrame: Blood samples analysed up to 2 year follow up, estimated 4 years in total
measure: Accuracy, sensitivity, specificity and concordance index
timeFrame: For the duration of study, expected 4 years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beacon Hospital
state: Dublin 18
city: Drogheda
country: Ireland
facility: Our Lady of Lourdes Hospital Drogheda
state: Louth
city: Cork
country: Ireland
facility: Bon Secours
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St Vincent's Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Limerick
country: Ireland
facility: Midwestern Regional Hospital
city: Tallaght
country: Ireland
facility: Adelaide Meath National Childrens Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
References: