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Trial record 1 of 1 for:    NCT 02050997
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Plasma Biomarkers P-DAC, V1

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02050997
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Tracking Information
First Submitted Date January 24, 2014
First Posted Date January 31, 2014
Last Update Posted Date January 9, 2020
Study Start Date October 2013
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2014)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 18, 2016)
  • 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
Original Secondary Outcome Measures
 (submitted: January 29, 2014)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Plasma Biomarkers P-DAC, V1
Official Title Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)
Brief 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.
Detailed 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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients on this study must have pancreatic ductal adenocarcinoma.
Condition Pancreatic Ductal Adenocarcinoma
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 7, 2020)
169
Original Estimated Enrollment
 (submitted: January 29, 2014)
240
Study Completion Date Not Provided
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02050997
Other Study ID Numbers CTRIAL-IE (ICORG) 12-31
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor Cancer Trials Ireland
Collaborators Not Provided
Investigators Not Provided
PRS Account Cancer Trials Ireland
Verification Date July 2019