Pancreatic Cancer Recurrence in the Netherlands

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605237
• Other study ID #: 18-036/C
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• PDAC
• Recurrence

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