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Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation

NCT ID: NCT07200466

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

735 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-23

Study Completion Date

2032-10-16

Brief Summary

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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:

* 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

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.

Intervention Type 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.

Interventions

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ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)
* Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)

Exclusion Criteria

* Unable to give informed consent
* No understanding of Dutch or English language
* Rare types of endometrial cancer, such as endometrial stroma cell sarcoma
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role collaborator

Amphia Hospital

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Elkerliek Hospital

OTHER

Sponsor Role collaborator

St. Anna Ziekenhuis, Geldrop, Netherlands

OTHER

Sponsor Role collaborator

Jeroen Bosch Ziekenhuis, s'-Hertogenbosch

UNKNOWN

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Canisius Wilhelmina Ziekenhuis (CWZ)

UNKNOWN

Sponsor Role collaborator

Maxima Medical Center

OTHER

Sponsor Role collaborator

Bernhoven Hospital

OTHER

Sponsor Role collaborator

Maas Hospital Pantein

OTHER

Sponsor Role collaborator

Slingeland Hospital

OTHER

Sponsor Role collaborator

Streekziekenhuis Koningin Beatrix

UNKNOWN

Sponsor Role collaborator

Gelderse Vallei Hospital

OTHER

Sponsor Role collaborator

Comprehensive Cancer Centre The Netherlands

OTHER

Sponsor Role collaborator

Stichting PAMM

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rijnstate

Arnhem, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Slingeland Hospital

Doetinchem, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Gelderse Vallei

Ede, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Streekziekenhuis Koningin Beatrix

Winterswijk, Gelderland, Netherlands

Site Status NOT_YET_RECRUITING

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, Netherlands

Site Status RECRUITING

Amphia

Breda, North Brabant, Netherlands

Site Status RECRUITING

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Site Status RECRUITING

St. Anna Hospital

Geldrop, North Brabant, Netherlands

Site Status RECRUITING

Elkerliek Hospital

Helmond, North Brabant, Netherlands

Site Status RECRUITING

Elisabeth-Tweesteden Hospital

Tilburg, North Brabant, Netherlands

Site Status NOT_YET_RECRUITING

Bernhoven Hospital

Uden, North Brabant, Netherlands

Site Status NOT_YET_RECRUITING

Maxima Medical Center

Veldhoven, North Brabant, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Ruben C.G. Koek, MD / Drs

Role: CONTACT

[email protected]
+31631015109

Hanny M.A. Pijnenborg, MD, PhD

Role: CONTACT

[email protected]

Facility Contacts

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Hanny M.A. Pijnenborg, MD PhD

Role: primary

[email protected]
+31 024 361 1111

References

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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.

Reference Type BACKGROUND
PMID: 35992828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32413043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35939115 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.endorisk.eu/

ENDORISK website with information relating to the ENDORISK model and the research team

Other Identifiers

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14032

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL86300.000.24

Identifier Type: -

Identifier Source: org_study_id