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| Name | Class |
|---|---|
| Amsterdam UMC, location VUmc | OTHER |
| Erasmus Medical Center | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Radboud University Medical Center |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of symptoms at time of (suspected) recurrence | Which symptoms are associated with PDAC recurrence? | Within a follow-up period up to 5 years |
| Performance score at time of recurrence detection |
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Inclusion Criteria:
Exclusion Criteria:
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All patients registered within the prospective, mandatory Dutch Pancreatic Cancer Audit who underwent resection of histologically proven PDAC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris van Goor, MD | Contact | +31631917882 | I.W.J.vanGoor-5@umcutrecht.nl | |
| Lois Daamen, MD | Contact | +31651223276 | L.A.Daamen-3@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| I. Quintus Molenaar, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Utrecht | Recruiting | Utrecht | 3584 CX | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2017 | Oct 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 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 |
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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 | 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 | How often is PDAC recurrence histologically confirmed? | Within a follow-up period up to 5 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |