Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-28 @ 9:24 PM
Study NCT ID:
NCT07200466
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
ENDORISK Clinical Implementation Study
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDORISK-I
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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 14032 | OTHER_GRANT | Koningin Wilhelmina Fonds voor Nederlandse Kankerbestrijding | View |