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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
735

participants targeted

Target at P75+ for not_applicable

Timeline
78mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Oct 2025Oct 2032

First Submitted

Initial submission to the registry

July 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

October 23, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2032

Last Updated

March 27, 2026

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 23, 2025

Last Update Submit

March 25, 2026

Conditions

Endometrial Cancer

Keywords

ENDORISKEndometrial Cancersurgical stagingrisk stratificationlymph node metastaseslymphadenectomysentinel node

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (10)

  • 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

    12 weeks after primary surgery

  • Health-related quality of life (HRQoL) compared to standard care

    12 months after primary surgery

  • Treatment-related morbidity compared to standard care

    12 weeks after primary surgery

  • Treatment related morbidity compared to standard care

    12 months after primary surgery

  • +5 more secondary outcomes

Other Outcomes (2)

  • Charlson-index

    12 weeks after primary surgery

  • Health literacy

    12 weeks after primary surgery

Study Arms (2)

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.

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

Interventions

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.

Intervention

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Rijnstate

Arnhem, Gelderland, Netherlands

NOT YET RECRUITING

Slingeland Hospital

Doetinchem, Gelderland, Netherlands

NOT YET RECRUITING

Gelderse Vallei

Ede, Gelderland, Netherlands

NOT YET RECRUITING

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

NOT YET RECRUITING

Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, Gelderland, Netherlands

NOT YET RECRUITING

Streekziekenhuis Koningin Beatrix

Winterswijk, Gelderland, Netherlands

NOT YET RECRUITING

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, Netherlands

RECRUITING

Amphia

Breda, North Brabant, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, North Brabant, Netherlands

RECRUITING

St. Anna Hospital

Geldrop, North Brabant, Netherlands

RECRUITING

Elkerliek Hospital

Helmond, North Brabant, Netherlands

RECRUITING

Elisabeth-Tweesteden Hospital

Tilburg, North Brabant, Netherlands

RECRUITING

Bernhoven Hospital

Uden, North Brabant, Netherlands

NOT YET RECRUITING

Maxima Medical Center

Veldhoven, North Brabant, Netherlands

RECRUITING

Related Publications (3)

  • 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.

    PMID: 35992828BACKGROUND

  • 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.

    PMID: 32413043BACKGROUND

  • 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.

    PMID: 35939115BACKGROUND

Related Links

MeSH Terms

Conditions

Endometrial NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ruben C.G. Koek, MD / Drs

CONTACT

+31631015109ruben.koek@radboudumc.nl

Hanny M.A. Pijnenborg, MD, PhD

CONTACT

hanny.ma.pijnenborg@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

October 1, 2025

Study Start

October 23, 2025

Primary Completion (Estimated)

October 16, 2027

Study Completion (Estimated)

October 16, 2032

Last Updated

March 27, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD will be available after the end of the study.
Access Criteria
Researchers within the RadboudUMC will be able to get access upon request and review of research aim/protocol

Locations

NL(14)