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Pancreatic Cancer Recurrence in the Netherlands

Sponsor
UMC Utrecht (Other)
Overall Status
Recruiting
CT.gov ID
NCT04605237
Collaborator
Amsterdam UMC, location VUmc (Other), Erasmus Medical Center (Other), Catharina Ziekenhuis Eindhoven (Other), Radboud University Medical Center (Other), University Medical Center Groningen (Other), Jeroen Bosch Ziekenhuis (Other), Leiden University Medical Center (Other), Maastricht University Medical Center (Other), Maasstad Hospital (Other), Amphia Hospital (Other), Onze Lieve Vrouwe Gasthuis (Other), Reinier de Graaf Groep (Other), Isala (Other), St. Antonius Hospital (Other)
1,750
Enrollment
1
Location
108
Anticipated Duration (Months)
16.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (PDAC) in the Netherlands, with regard to the detection, treatment and survival of PDAC recurrence.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Detection, Treatment and Survival of Pancreatic Cancer Recurrence in the Netherlands
    Actual Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of PDAC recurrence [Within a follow-up period up to 5 years]

      Incidence of PDAC recurrence within the Netherlands; PDAC recurrence is either pathologically proven, or suspected through cross-sectional imaging, preferably confirmed by consensus during a multidisciplinary meeting.

    2. Patterns of PDAC recurrence [Within a follow-up period up to 5 years]

      Asymptomatic vs. symptomatic: Symptomatic recurrence is defined as the presence of symptoms suggestive for PDAC recurrence at recurrence diagnosis. If PDAC recurrence is detected in absence of suspected symptoms, disease recurrence was defined as asymptomatic. First site of recurrence: isolated local recurrence, liver-only, lung-only, multiple-site, other isolated distant Early vs. late recurrence: disease-free survival ≥12 months vs. <12 months

    3. Treatment of PDAC recurrence [Within a follow-up period up to 5 years]

      Either systemic and/or local treatment or best-supportive-care

    4. Survival [Within a follow-up period up to 5 years]

      Overall survival (from the time of resection), disease-free survival (from the time of resection), post-recurrence survival (from the time of recurrence diagnosis)

    Secondary Outcome Measures

    1. Presence of symptoms at time of (suspected) recurrence [Within a follow-up period up to 5 years]

      Which symptoms are associated with PDAC recurrence?

    2. Performance score at time of recurrence detection [Within a follow-up period up to 5 years]

      What is the ECOG performance score of patients at time of recurrence diagnosis?

    3. Use of imaging procedures during follow-up [Within a follow-up period up to 5 years]

      How much imaging procedures are performed during postoperative follow-up for the detection of PDAC recurrence? Are these procedures routinely performed?

    4. Number of histologically confirmed recurrences [Within a follow-up period up to 5 years]

      How often is PDAC recurrence histologically confirmed?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing a pancreatic resection (PPPD, Whipple, distal pancreatectomy or total pancreatectomy) for histologically proven PDAC in one of the 16 Dutch centers for pancreatic surgery
    Exclusion Criteria:
    • Patients with 30-day postoperative mortality

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UMC Utrecht Utrecht Netherlands 3584 CX

    Sponsors and Collaborators

    • UMC Utrecht
    • Amsterdam UMC, location VUmc
    • Erasmus Medical Center
    • Catharina Ziekenhuis Eindhoven
    • Radboud University Medical Center
    • University Medical Center Groningen
    • Jeroen Bosch Ziekenhuis
    • Leiden University Medical Center
    • Maastricht University Medical Center
    • Maasstad Hospital
    • Amphia Hospital
    • Onze Lieve Vrouwe Gasthuis
    • Reinier de Graaf Groep
    • Isala
    • St. Antonius Hospital

    Investigators

    • Principal Investigator: I. Quintus Molenaar, MD, PhD, UMC Utrecht

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. I.Q. Molenaar, Prof. dr., UMC Utrecht
    ClinicalTrials.gov Identifier:
    NCT04605237
    Other Study ID Numbers:
    • 18-036/C
    First Posted:
    Oct 27, 2020
    Last Update Posted:
    Oct 27, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Recurrence

    Study Results

    No Results Posted as of Oct 27, 2020