Plasma Biomarkers P-DAC, V1

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Cancer Trials Ireland
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland
ClinicalTrials.gov Identifier:
NCT02050997
First received: January 24, 2014
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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.

Condition
Pancreatic Ductal Adenocarcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (P-DAC Plasma Biomarker Study)

Further study details as provided by Cancer Trials Ireland:

Primary Outcome Measures:
  • Time to disease recurrence [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ] [ Designated as safety issue: No ]
    Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence


Secondary Outcome Measures:
  • Rate of progression free survival [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ] [ Designated as safety issue: No ]
    To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival

  • Accuracy, sensitivity, specificity and concordance index [ Time Frame: For the duration of study, expected 4 years ] [ Designated as safety issue: No ]
    Aim to validate a panel of predicitive 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


Estimated Enrollment: 240
Study Start Date: October 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

This study will involve two cohort groups, all patients involved will have PDAC.

Cohort A will involve resectable PDAC patients who will receive standard treatment of CT (with/without radiotherapy).

Cohort B will comprise of unresectable advanced PDAC patients and metastatic PDAC patients, both of whom will receive standard treatment of CT (with/without radiotherapy).

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients on this study must have pancreatic ductal adenocarcinoma.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050997

Locations
Ireland
Beacon Hospital Recruiting
Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland
Contact: Ray McDermott    01 293 6600      
Contact: Dr Ray McDermott         
Bon Secours Recruiting
Cork, Ireland
Contact: Contact Name    021 454 2807      
Principal Investigator: Dr Brian Bird         
Cork University Hospital Recruiting
Cork, Ireland
Contact: Contact Person    021-4935362      
Principal Investigator: Derek Power, Dr         
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01-8377547      
Principal Investigator: Liam Grogan, Prof         
St Vincent's Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01-2214117      
Principal Investigator: Ray McDermott, Dr         
Galway University Hospital Recruiting
Galway, Ireland
Contact: Contact Person    091-543789      
Principal Investigator: Leonard Gregory, Dr         
Midwestern Regional Hospital Active, not recruiting
Limerick, Ireland
Adelaide Meath National Childrens Hospital Recruiting
Tallaght, Ireland, 24
Contact: Contact Person    01-4142000      
Principal Investigator: MinYuen Teo, Dr         
Waterford Regional Hospital Recruiting
Waterford, Ireland
Contact: Contact Person    051-848000      
Principal Investigator: Anne Horgan, Dr         
Sponsors and Collaborators
Cancer Trials Ireland
  More Information

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT02050997     History of Changes
Other Study ID Numbers: ICORG 12-31 
Study First Received: January 24, 2014
Last Updated: June 27, 2016
Health Authority: Ireland: Health Information and Quality Authority

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 30, 2016