Tests a risk model for lymph node spread in newly diagnosed early endometrial cancer
Tests a personalized risk tool for lymph node spread in patients with early endometrial cancer.
Plain-language title generated from the registry record
Registry title: Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation
Key facts
- Where
- 's-Hertogenbosch, Arnhem, Breda, Doetinchem, Ede, Eindhoven, Geldrop, Helmond, Nijmegen, Tilburg, Uden, Veldhoven, and Winterswijk, NetherlandsSee the 14 sites
Where in Netherlands
- Jeroen Bosch Hospital's-Hertogenbosch, NetherlandsTaking people
- RijnstateArnhem, NetherlandsTaking people
- AmphiaBreda, NetherlandsTaking people
- Slingeland HospitalDoetinchem, NetherlandsNot yet recruiting
- Gelderse ValleiEde, NetherlandsTaking people
- Catharina hospitalEindhoven, NetherlandsTaking people
- St. Anna HospitalGeldrop, NetherlandsTaking people
- Elkerliek HospitalHelmond, NetherlandsTaking people
- Canisius Wilhelmina Ziekenhuis (CWZ)Nijmegen, NetherlandsNot yet recruiting
- RadboudumcNijmegen, NetherlandsTaking people
- Elisabeth-TweeSteden HospitalTilburg, NetherlandsTaking people
- Bernhoven HospitalUden, NetherlandsTaking people
- Maxima Medical CenterVeldhoven, NetherlandsTaking people
- Streekziekenhuis Koningin BeatrixWinterswijk, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud University Medical Center
- Trial code
- NCT07200466
- Record updated
- 29 July 2026
- Original description
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:Read full original descriptionShow less
ENDORISK Clinical Implementation Study
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
Inclusion: Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted); Eligible for primary surgical treatment (neo-adjuvant therapy is permitted).
Exclusion: Rare types of endometrial cancer, such as endometrial stroma cell sarcoma; Unable to give informed consent; No understanding of Dutch or English language.