Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT07200466
Brief 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
Study:
NCT07200466
Study Brief:
Protocol Section:
NCT07200466