RecruitingNot ApplicableNCT07200466

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

ENDORISK Clinical Implementation Study


Sponsor

Radboud University Medical Center

Enrollment

735 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 prospectively evaluated in both regions since March 2022 in the 'evaluation of care in endometrial cancer' study (2021-7400). Study population: all consecutive patients recently diagnosed with early stage EC who are eligible for surgical treatment, who understand Dutch and are able to fill in a digital or paper questionnaire can be included. Main study parameters/endpoints: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate implementation of ENDORISK in daily clinical practice by investigating: * The proportion of identified LNM in patients with lymph node staging (positive predictive value (PPV)) compared to standard care * Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care * Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care * Patients' disease- specific-, overall survival, and health-related quality of life compared to standard care * Patients' and doctors' use of and experiences with the ENDORISK-model * Impact of ENDORISK on regional care costs


Eligibility

Sex: FEMALEMin Age: 45 Years

Inclusion Criteria2

  • Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)
  • Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)

Exclusion Criteria3

  • Unable to give informed consent
  • No understanding of Dutch or English language
  • Rare types of endometrial cancer, such as endometrial stroma cell sarcoma

Interventions

DIAGNOSTIC_TESTENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.

The intervention group are patients receiving a personalized risk on lymph node metastases as predicted by the ENDORISK model, they also receive a treatment plan (hysterectomy + bilateral salpingo-oophorectomy with or without lymph node surgery) based on this personalized risk.


Locations(14)

Rijnstate

Arnhem, Gelderland, Netherlands

Slingeland Hospital

Doetinchem, Gelderland, Netherlands

Gelderse Vallei

Ede, Gelderland, Netherlands

Radboudumc

Nijmegen, Gelderland, Netherlands

Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, Gelderland, Netherlands

Streekziekenhuis Koningin Beatrix

Winterswijk, Gelderland, Netherlands

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, Netherlands

Amphia

Breda, North Brabant, Netherlands

Catharina Hospital

Eindhoven, North Brabant, Netherlands

St. Anna Hospital

Geldrop, North Brabant, Netherlands

Elkerliek Hospital

Helmond, North Brabant, Netherlands

Elisabeth-Tweesteden Hospital

Tilburg, North Brabant, Netherlands

Bernhoven Hospital

Uden, North Brabant, Netherlands

Maxima Medical Center

Veldhoven, North Brabant, Netherlands

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NCT07200466


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