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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04605237
Other study ID # 18-036/C
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date July 1, 2023

Study information

Verified date February 2023
Source UMC Utrecht
Contact Iris van Goor, MD
Phone +31631917882
Email I.W.J.vanGoor-5@umcutrecht.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1750
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (15)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of PDAC recurrence 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
Primary Patterns of PDAC recurrence 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
Primary Treatment of PDAC recurrence Either systemic and/or local treatment or best-supportive-care Within a follow-up period up to 5 years
Primary Survival 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 Presence of symptoms at time of (suspected) recurrence Which symptoms are associated with PDAC recurrence? Within a follow-up period up to 5 years
Secondary Performance score at time of recurrence detection What is the ECOG performance score of patients at time of recurrence diagnosis? Within a follow-up period up to 5 years
Secondary Use of imaging procedures during follow-up 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
Secondary Number of histologically confirmed recurrences How often is PDAC recurrence histologically confirmed? Within a follow-up period up to 5 years
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