Actively Recruiting

Phase Not Applicable
Age: 45Years +
FEMALE
NCT07200466

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

Led by Radboud University Medical Center · Updated on 2026-03-27

735

Participants Needed

14

Research Sites

364 weeks

Total Duration

On this page

Sponsors

R

Radboud University Medical Center

Lead Sponsor

E

Elisabeth-TweeSteden Ziekenhuis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)
  • Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 14 locations

1

Rijnstate

Arnhem, Gelderland, Netherlands

Not Yet Recruiting

2

Slingeland Hospital

Doetinchem, Gelderland, Netherlands

Not Yet Recruiting

3

Gelderse Vallei

Ede, Gelderland, Netherlands

Not Yet Recruiting

4

Radboudumc

Nijmegen, Gelderland, Netherlands, 6525GA

Not Yet Recruiting

5

Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, Gelderland, Netherlands

Not Yet Recruiting

6

Streekziekenhuis Koningin Beatrix

Winterswijk, Gelderland, Netherlands

Not Yet Recruiting

7

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, Netherlands

Actively Recruiting

8

Amphia

Breda, North Brabant, Netherlands

Actively Recruiting

9

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Actively Recruiting

10

St. Anna Hospital

Geldrop, North Brabant, Netherlands

Actively Recruiting

11

Elkerliek Hospital

Helmond, North Brabant, Netherlands

Actively Recruiting

12

Elisabeth-Tweesteden Hospital

Tilburg, North Brabant, Netherlands

Actively Recruiting

13

Bernhoven Hospital

Uden, North Brabant, Netherlands

Not Yet Recruiting

14

Maxima Medical Center

Veldhoven, North Brabant, Netherlands

Actively Recruiting

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Research Team

R

Ruben C.G. Koek, MD / Drs

CONTACT

H

Hanny M.A. Pijnenborg, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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