Plasma Biomarkers P-DAC, V1

Cancer Trials Ireland

Status: Terminated

Conditions: Pancreatic Ductal Adenocarcinoma

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02050997

CTRIAL-IE (ICORG) 12-31

Details and patient eligibility

About

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.

Full 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

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

169 participants in 2 patient groups

B

Description:

Unresectable or metastatic PDAC patients who will receive standard treatment of CT +/- radiotherapy

A

Description:

Resectable PDAC patients who will receive standard treatment of CT +/- radiotherapy