Plasma Biomarkers P-DAC, V1

N/ATerminatedNCT02050997

Cancer Trials Ireland169 enrolled

Overview

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.

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

169

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Beacon Hospital

Dublin, Dublin 18, Ireland

Our Lady of Lourdes Hospital Drogheda

Drogheda, Louth, Ireland

Bon Secours

Cork, Ireland

Beaumont Hospital

Dublin, Ireland

Outcomes

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

Data from ClinicalTrials.gov

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