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PaCaReg: PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma

Sponsor
University of Ulm (Other)
Overall Status
Recruiting
CT.gov ID
NCT04099134
Collaborator
(none)
5,000
Enrollment
1
Location
131.7
Anticipated Duration (Months)
38
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    PaCaReg: A Multicenter Registry Trial for the Assessement of Clinical, Epidemiological and Biological Profiles in Patients With Pancreatic Ductal Adenocarcinoma
    Actual Study Start Date :
    Oct 10, 2018
    Anticipated Primary Completion Date :
    Oct 1, 2028
    Anticipated Study Completion Date :
    Oct 1, 2029

    Outcome Measures

    Primary Outcome Measures

    1. General assessment of applied therapy modalities in pancreatic cancer [First diagnose to death or end of surveillance (5 years after curative resection)]

    2. Quality of life in pancreatic cancer patients [First diagnose to death or end of surveillance (5 years after curative resection)]

      EORTC QLQ c30 and PAN 26

    Secondary Outcome Measures

    1. General epidemiologic assessment [First diagnose to death or end of surveillance (5 years after curative resection)]

      Epidemiologic questionaire

    2. Assessment of tumor surveillance in pancreatic cancer patients [First diagnose to death or end of surveillance (5 years after curative resection)]

    3. Evaluation of predictive and prognostic markers [First diagnose to death or end of surveillance (5 years after curative resection)]

    Eligibility Criteria

    Criteria

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

    • Treatment naive histologically or cytologically proven pancreatic ductal adenocarcinoma (PDAC) or highly suspicious diagnosis (only pre-curative-intended resection)

    • Age =>18 years

    • written informed consent

    Exclusion Criteria:

    • papillary cancer

    • neuroendocrine pancreatic tumors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitätsklinikum Ulm Ulm Germany

    Sponsors and Collaborators

    • University of Ulm

    Investigators

    • Principal Investigator: Thomas Seufferlein, MD, Ulm University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Seufferlein, Head of department for internal medicine I, University of Ulm
    ClinicalTrials.gov Identifier:
    NCT04099134
    Other Study ID Numbers:
    • PaCaReg
    First Posted:
    Sep 23, 2019
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Sep 25, 2019