ENDORISK Clinical Implementation Study

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: f
View:

• Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)

• Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)

Locations
Other Locations
Netherlands
Jeroen Bosch Hospital
RECRUITING
's-hertogenbosch
Rijnstate
NOT_YET_RECRUITING
Arnhem
Amphia
RECRUITING
Breda
Slingeland Hospital
NOT_YET_RECRUITING
Doetinchem
Gelderse Vallei
NOT_YET_RECRUITING
Ede
Catharina Hospital
RECRUITING
Eindhoven
St. Anna Hospital
RECRUITING
Geldrop
Elkerliek Hospital
RECRUITING
Helmond
Canisius Wilhelmina Ziekenhuis (CWZ)
NOT_YET_RECRUITING
Nijmegen
Radboudumc
NOT_YET_RECRUITING
Nijmegen
Elisabeth-Tweesteden Hospital
NOT_YET_RECRUITING
Tilburg
Bernhoven Hospital
NOT_YET_RECRUITING
Uden
Maxima Medical Center
RECRUITING
Veldhoven
Streekziekenhuis Koningin Beatrix
NOT_YET_RECRUITING
Winterswijk
Contact Information
Primary
Ruben C.G. Koek, MD / Drs
ruben.koek@radboudumc.nl
+31631015109
Backup
Hanny M.A. Pijnenborg, MD, PhD
hanny.ma.pijnenborg@radboudumc.nl
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2032-10-16
Participants
Target number of participants: 735
Treatments
No_intervention: Control
The control arm is a group of patients from our previous 'evaluation of care' study which underwent standard care for endometrial cancer between march of 2022 and the start of the ENDORISK-I study. This group serves as a control group for the intervention arm.
Experimental: Intervention
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, Maxima Medical Center, Amphia Hospital, Maas Hospital Pantein, Catharina Ziekenhuis Eindhoven, Elkerliek Hospital, Slingeland Hospital, Gelderse Vallei Hospital, Jeroen Bosch Ziekenhuis, s'-Hertogenbosch, Comprehensive Cancer Centre The Netherlands, Bernhoven Hospital, St. Anna Ziekenhuis, Geldrop, Netherlands, Canisius Wilhelmina Ziekenhuis (CWZ), Stichting PAMM, Rijnstate Hospital, Streekziekenhuis Koningin Beatrix
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov