Pancreatic Cancer Recurrence in the Netherlands

NCT04605237 | Unknown

• 1 other identifier: 18-036/C
• Study Type: observational
• Target: 1,750
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreas Cancer; PDAC

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Treatment of PDAC recurrence

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

  Within a follow-up period up to 5 years

• 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 Outcomes (4)

• Presence of symptoms at time of (suspected) recurrence

  Within a follow-up period up to 5 years

• Performance score at time of recurrence detection

  Within a follow-up period up to 5 years

• Use of imaging procedures during follow-up

  Within a follow-up period up to 5 years

• Number of histologically confirmed recurrences

  Within a follow-up period up to 5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with 30-day postoperative mortality

Sponsors & Collaborators

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

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• I. Quintus Molenaar, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris van Goor, MD

CONTACT

+31631917882; I.W.J.vanGoor-5@umcutrecht.nl

Lois Daamen, MD

CONTACT

+31651223276; L.A.Daamen-3@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 27, 2020
• Study Start: January 1, 2014
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

NL (1)