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| ID | Type | Description | Link |
|---|---|---|---|
| 14032 | Other Grant/Funding Number | Koningin Wilhelmina Fonds voor Nederlandse Kankerbestrijding |
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| Name | Class |
|---|---|
| Elisabeth-TweeSteden Ziekenhuis | OTHER |
| Amphia Hospital | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Elkerliek Hospital |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer. | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care. | from enrolment to surgery | |
| Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care | The lymph node metastases in patients undergoing lymph node staging will be determined by pathology report on the surgical specimen. The positive predicting value will be compared to the positive predictive value of standard care. | From enrolment to time of surgery |
| Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care, measured by questionnaires. | Information provision score: Questionnaire EORTC Quality of Life Questionnaire (QLQ)-INFO25 with additional questions specific to ENDORISK use. Shared-decision making score: Shared Decision Making Questionnaire SDM-Q-9 with additional questions specific to ENDORISK use | From enrolment to 12 weeks post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' 5-year disease- specific-, overall survival (DSS, OS), compared to standard care; | from enrolment to 5-year post surgery | |
| Health related quality of life (HRQoL) compared to standard care | as measured by questionnaire: EORTC Quality of life questionnaire (QLQ) -C30 |
| Measure | Description | Time Frame |
|---|---|---|
| Charlson-index | Charlson-index as reported by participants and as reported by clinician/researcher from patient records | 12 weeks after primary surgery |
| Health literacy | Health Literacy as reported by participants through a questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruben C.G. Koek, MD / Drs | Contact | +31631015109 | ruben.koek@radboudumc.nl | |
| Hanny M.A. Pijnenborg, MD, PhD | Contact | hanny.ma.pijnenborg@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate | Not yet recruiting | Arnhem | Gelderland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35992828 | Background | Vinklerova P, Ovesna P, Hausnerova J, Pijnenborg JMA, Lucas PJF, Reijnen C, Vrede S, Weinberger V. External validation study of endometrial cancer preoperative risk stratification model (ENDORISK). Front Oncol. 2022 Aug 3;12:939226. doi: 10.3389/fonc.2022.939226. eCollection 2022. | |
| 32413043 | Background | Reijnen C, Gogou E, Visser NCM, Engerud H, Ramjith J, van der Putten LJM, van de Vijver K, Santacana M, Bronsert P, Bulten J, Hirschfeld M, Colas E, Gil-Moreno A, Reques A, Mancebo G, Krakstad C, Trovik J, Haldorsen IS, Huvila J, Koskas M, Weinberger V, Bednarikova M, Hausnerova J, van der Wurff AAM, Matias-Guiu X, Amant F; ENITEC Consortium; Massuger LFAG, Snijders MPLM, Kusters-Vandevelde HVN, Lucas PJF, Pijnenborg JMA. Preoperative risk stratification in endometrial cancer (ENDORISK) by a Bayesian network model: A development and validation study. PLoS Med. 2020 May 15;17(5):e1003111. doi: 10.1371/journal.pmed.1003111. eCollection 2020 May. |
| Label | URL |
|---|---|
| ENDORISK website with information relating to the ENDORISK model and the research team | View source |
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Only anonymized datasets (without patient numbers, date of birth or name) will be shared with other people relevant to the study or relevant to additional studies as reported in the patient information folder.
Patients are requested whether or not they give permission to use anonymized data from this study for further research into cervical cancer.
IPD will be available after the end of the study.
Researchers within the RadboudUMC will be able to get access upon request and review of research aim/protocol
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2026 |
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| OTHER |
| St. Anna Ziekenhuis, Geldrop, Netherlands | OTHER |
| Jeroen Bosch Ziekenhuis, s'-Hertogenbosch | UNKNOWN |
| Rijnstate Hospital | OTHER |
| Canisius-Wilhelmina Hospital | OTHER |
| Maxima Medical Center | OTHER |
| Bernhoven Hospital | OTHER |
| Maas Hospital Pantein | OTHER |
| Slingeland Hospital | OTHER |
| Streekziekenhuis Koningin Beatrix | UNKNOWN |
| Gelderse Vallei Hospital | OTHER |
| Comprehensive Cancer Centre The Netherlands | OTHER |
| Stichting PAMM | UNKNOWN |
Patients will receive a personalized treatment plan based on the risk of lymph node metastases as predicted by the ENDORISK model. Patients with low grade endometrial cancer (EC) (grade I-II) at high risk of lymph node metastases might therefore undergo additional surgical staging, through either sentinel lymph node procedure or lymphadenectomy. Patients with low grade EC (grade I-II) at low-risk of lymph node metastases are counselled to undergo standard treatment, which involves hysterectomy with bilateral salpingo-oophorectomy. Patients with high grade EC (grade III), receive their personalized risk but will undergo standard care to further validate the ENDORISK model in this group.
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| 12 weeks after primary surgery |
| Health-related quality of life (HRQoL) compared to standard care | as measured by questionnaire: EORTC QLQ-C30 | 12 months after primary surgery |
| Treatment-related morbidity compared to standard care | As measured by questionnaire: EORTC QLQ- Endometrial cancer (EN) 24 | 12 weeks after primary surgery |
| Treatment related morbidity compared to standard care | As measured by questionnaire: EORTC QLQ-EN24 and questionnaires about lymphoedema: EORTC IL76 & Lymphoedema quality of Life (LYMQOL) | 12 months after primary surgery |
| Clinicians' experiences with ENDORISK care | Questionnaire at baseline | at baseline |
| Clinicians' experiences with ENDORISK care | Questionnaire at 9 months | 9 months after start of inclusions |
| Clinicians' experiences with ENDORISK care | Questionnaire at 18 months | 18 months after start of inclusions |
| Clinicians' experiences with ENDORISK care | In depth interviews with a sample of participating clinicians to evaluate user experiences. | Within 1 year of start of the inclusion period in their hospital. |
| Impact of ENDORISK on regional care costs | from enrolment to the end of inclusions |
| 12 weeks after primary surgery |
| Slingeland Hospital | Not yet recruiting | Doetinchem | Gelderland | Netherlands |
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| Gelderse Vallei | Recruiting | Ede | Gelderland | Netherlands |
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| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525GA | Netherlands |
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| Canisius Wilhelmina Ziekenhuis (CWZ) | Not yet recruiting | Nijmegen | Gelderland | Netherlands |
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| Streekziekenhuis Koningin Beatrix | Not yet recruiting | Winterswijk | Gelderland | Netherlands |
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| Jeroen Bosch Hospital | Recruiting | 's-Hertogenbosch | North Brabant | Netherlands |
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| Amphia | Recruiting | Breda | North Brabant | Netherlands |
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| Catharina Hospital | Recruiting | Eindhoven | North Brabant | Netherlands |
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| St. Anna Hospital | Recruiting | Geldrop | North Brabant | Netherlands |
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| Elkerliek Hospital | Recruiting | Helmond | North Brabant | Netherlands |
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| Elisabeth-Tweesteden Hospital | Recruiting | Tilburg | North Brabant | Netherlands |
|
| Bernhoven Hospital | Not yet recruiting | Uden | North Brabant | Netherlands |
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| Maxima Medical Center | Recruiting | Veldhoven | North Brabant | Netherlands |
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| 35939115 | Background | Grube M, Reijnen C, Lucas PJF, Kommoss F, Kommoss FKF, Brucker SY, Walter CB, Oberlechner E, Kramer B, Andress J, Neis F, Staebler A, Pijnenborg JMA, Kommoss S. Improved preoperative risk stratification in endometrial carcinoma patients: external validation of the ENDORISK Bayesian network model in a large population-based case series. J Cancer Res Clin Oncol. 2023 Jul;149(7):3361-3369. doi: 10.1007/s00432-022-04218-4. Epub 2022 Aug 8. |
| Mar 23, 2026 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2025 | Sep 9, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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