Plasma Biomarkers P-DAC, V1

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02050997
• Other study ID #: CTRIAL-IE (ICORG) 12-31
• Status: Terminated
• Start date: May 26, 2014
• Est. completion date: December 2021

Study information

• Verified date: April 2023
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 169
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Locations

Country	Name	City	State
Ireland	Bon Secours	Cork
Ireland	Our Lady of Lourdes Hospital Drogheda	Drogheda	Louth
Ireland	Beacon Hospital	Dublin	Dublin 18
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
Ireland	Waterford Regional Hospital	Waterford

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease recurrence	Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence	Blood samples analysed up to 2 year follow up, estimated 4 years in total
Secondary	Rate of progression free survival	To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival	Blood samples analysed up to 2 year follow up, estimated 4 years in total
Secondary	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	For the duration of study, expected 4 years