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Plasma Biomarkers P-DAC, V1

Sponsor
Cancer Trials Ireland (Other)
Overall Status
Terminated
CT.gov ID
NCT02050997
Collaborator
(none)
169
Enrollment
9
Locations
90.2
Actual Duration (Months)
18.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    169 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)
    Actual Study Start Date :
    May 26, 2014
    Actual Primary Completion Date :
    Dec 1, 2021
    Actual Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Time to disease recurrence [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

    Secondary Outcome Measures

    1. Rate of progression free survival [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

    2. Accuracy, sensitivity, specificity and concordance index [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Beacon Hospital Bracken Rd, Sandyford Industrial Estate Dublin 18 Ireland
    2 Our Lady of Lourdes Hospital Drogheda Drogheda Louth Ireland
    3 Bon Secours Cork Ireland
    4 Beaumont Hospital Dublin Ireland
    5 St Vincent's Hospital Dublin Ireland
    6 Galway University Hospital Galway Ireland
    7 Midwestern Regional Hospital Limerick Ireland
    8 Adelaide Meath National Childrens Hospital Tallaght Ireland 24
    9 Waterford Regional Hospital Waterford Ireland

    Sponsors and Collaborators

    • Cancer Trials Ireland

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Trials Ireland
    ClinicalTrials.gov Identifier:
    NCT02050997
    Other Study ID Numbers:
    • CTRIAL-IE (ICORG) 12-31
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Jan 21, 2022