Pancreatic Cancer Recurrence in the Netherlands

February 1, 2023 updated by: Prof. dr. I.Q. Molenaar, MD, PhD, UMC Utrecht

Detection, Treatment and Survival of Pancreatic Cancer Recurrence in the Netherlands

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Iris van Goor, MD
Phone Number: +31631917882
Email: I.W.J.vanGoor-5@umcutrecht.nl

Study Contact Backup

Name: Lois Daamen, MD
Phone Number: +31651223276
Email: L.A.Daamen-3@umcutrecht.nl

Study Locations

Netherlands
- - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - UMC Utrecht
    - Contact:
      
      Iris van Goor, MD
      
      Phone Number: +31631917882
      
      Email: I.W.J.vanGoor-5@umcutrecht.nl
    - Contact:
      
      Lois Daamen, MD
      
      Phone Number: +31651223276
      
      Email: L.A.Daamen-3@umcutrecht.nl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients registered within the prospective, mandatory Dutch Pancreatic Cancer Audit who underwent resection of histologically proven PDAC.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of PDAC recurrence Time Frame: 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.	Within a follow-up period up to 5 years
Patterns of PDAC recurrence Time Frame: 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	Within a follow-up period up to 5 years
Treatment of PDAC recurrence Time Frame: Within a follow-up period up to 5 years	Either systemic and/or local treatment or best-supportive-care	Within a follow-up period up to 5 years
Survival Time Frame: 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)	Within a follow-up period up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of symptoms at time of (suspected) recurrence Time Frame: Within a follow-up period up to 5 years	Which symptoms are associated with PDAC recurrence?	Within a follow-up period up to 5 years
Performance score at time of recurrence detection Time Frame: Within a follow-up period up to 5 years	What is the ECOG performance score of patients at time of recurrence diagnosis?	Within a follow-up period up to 5 years
Use of imaging procedures during follow-up Time Frame: 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?	Within a follow-up period up to 5 years
Number of histologically confirmed recurrences Time Frame: Within a follow-up period up to 5 years	How often is PDAC recurrence histologically confirmed?	Within a follow-up period up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Radboud University Medical Center

University Medical Center Groningen

Maastricht University Medical Center

Erasmus Medical Center

Catharina Ziekenhuis Eindhoven

Amsterdam UMC, location VUmc

St. Antonius Hospital

Leiden University Medical Center

Maasstad Hospital

Onze Lieve Vrouwe Gasthuis

Reinier de Graaf Groep

Jeroen Bosch Ziekenhuis

Isala

Amphia Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 24, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified