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Plasma Biomarkers P-DAC, V1

This study is currently recruiting participants.
Verified October 2016 by Cancer Trials Ireland
Sponsor:
ClinicalTrials.gov Identifier:
NCT02050997
First Posted: January 31, 2014
Last Update Posted: October 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cancer Trials Ireland
January 24, 2014
January 31, 2014
October 19, 2016
October 2013
December 2021   (Final data collection date for primary outcome measure)
Time to disease recurrence [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ]
Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence
Same as current
Complete list of historical versions of study NCT02050997 on ClinicalTrials.gov Archive Site
  • Rate of progression free survival [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ]
    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 ]
    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
  • Rate of progression free survival [ Time Frame: Blood samples analysed up to 2 year follow up, estimated 4 years in total ]
    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 ]
    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
Not Provided
Not Provided
 
Plasma Biomarkers P-DAC, V1
Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (P-DAC Plasma Biomarker Study)
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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All patients on this study must have pancreatic ductal adenocarcinoma.
Pancreatic Ductal Adenocarcinoma
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Not Provided
December 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Ireland
 
 
NCT02050997
ICORG 12-31
No
Not Provided
Not Provided
Cancer Trials Ireland
Cancer Trials Ireland
Not Provided
Not Provided
Cancer Trials Ireland
October 2016