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2014-01-01
2023-07-01
2023-07-01
1750
NCT04605237
UMC Utrecht
UMC Utrecht
OBSERVATIONAL
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.
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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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-10-15 | N/A | 2023-02-01 |
2020-10-24 | N/A | 2023-02-02 |
2020-10-27 | N/A | 2023-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | 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 | * 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 Outcome Measures | 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 | 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 |
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 |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
