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โ† Trials
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Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation

RecruitingNAAges 45 Years - anyFemaleRadboud University Medical Center
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In plain words

What the trial is, and whether it could suit you

Rationale: Preoperative identification of patients at risk for lymph node metastasis (LNM) is challenging in endometrial cancer (EC). Therefore, a Bayesian network model called ENDORISK was developed and validated in three external cohorts to improve preoperative risk stratification. The next step is to implement and evaluate whether use of the model improves daily clinical practice. Objective: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate whether implementation of ENDORISK in daily clinical practice improves preoperative risk stratification. Study design: A stepped wedge non inferiority study in which two oncology regions will consecutively start implementation of ENDORISK with one year interval. The ENDORISK model will be filled in and used in preoperative treatment counselling. Results will be compared to current standard clinical care which is prospect

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted) * Eligible for primary surgical treatment (neo-adjuvant therapy is permitted) Exclusion Criteria: * Unable to give informed consent * No understanding of Dutch or English language * Rare types of endometrial cancer, such as endometrial stroma cell sarcoma
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What it tests

  • ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.
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Where

14 sites
Rijnstate
Arnhem, Netherlands
Slingeland Hospital
Doetinchem, Netherlands
Gelderse Vallei
Ede, Netherlands
Radboudumc
Nijmegen, Netherlands
Canisius Wilhelmina Ziekenhuis (CWZ)
Nijmegen, Netherlands
Streekziekenhuis Koningin Beatrix
Winterswijk, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Amphia
Breda, Netherlands

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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