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

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

Conditions

• Endometrial Cancer

Interventions

DIAGNOSTIC_TEST

ENDORISK 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.

Sponsors & Collaborators

• Elisabeth-TweeSteden Ziekenhuis

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Elkerliek Hospital

  collaborator OTHER

• St. Anna Ziekenhuis, Geldrop, Netherlands

  collaborator OTHER

• Jeroen Bosch Ziekenhuis, s'-Hertogenbosch

  collaborator UNKNOWN

• Rijnstate Hospital

  collaborator OTHER

• Canisius Wilhelmina Ziekenhuis (CWZ)

  collaborator UNKNOWN

• Maxima Medical Center

  collaborator OTHER

• Bernhoven Hospital

  collaborator OTHER

• Maas Hospital Pantein

  collaborator OTHER

• Slingeland Hospital

  collaborator OTHER

• Streekziekenhuis Koningin Beatrix

  collaborator UNKNOWN

• Gelderse Vallei Hospital

  collaborator OTHER

• Comprehensive Cancer Centre The Netherlands

  collaborator OTHER

• Stichting PAMM

  collaborator UNKNOWN

• Radboud University Medical Center

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-23

Primary Completion

2027-10-16

Completion

2032-10-16

Countries

• Netherlands

Study Locations