Plasma Biomarkers P-DAC, V1

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT02050997
First received: January 24, 2014
Last updated: June 26, 2014
Last verified: January 2014
  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)

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

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
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
Cork University Hospital Active, not recruiting
Cork, Ireland
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
ICORG- All Ireland Cooperative Oncology Research Group
  More Information

No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT02050997     History of Changes
Other Study ID Numbers: ICORG 12-31
Study First Received: January 24, 2014
Last Updated: June 26, 2014
Health Authority: Ireland: Health Information and Quality Authority

Additional relevant MeSH terms:
Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Adenocarcinoma
Carcinoma
Carcinoma, Ductal
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014