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Endometrial CancerENDORISK-INCT07200466

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

A study testing ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer. in people with Endometrial Cancer, run by Radboud University Medical Center at 14 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
735 participants
Where
14 sitesNetherlands
Study dates
23 Oct 2025to 16 Oct 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ruben C.G. Koek, MD / Drs contact

+31631015109

ruben.koek@radboudumc.nl

Hanny M.A. Pijnenborg, MD, PhD contact

hanny.ma.pijnenborg@radboudumc.nl

14 sites in 1 country

Netherlands14 sites, 14 recruiting

  • Jeroen Bosch Hospital

    's-Hertogenbosch, North Brabant

    Louis van der Putten, MD PhD

    Recruiting

  • Rijnstate

    Arnhem, Gelderland

    Tijmen Bonestroo, MD PhD

    Recruiting

  • Amphia

    Breda, North Brabant

    Dennis van Hamont, MD PhD

    Recruiting

  • Slingeland Hospital

    Doetinchem, Gelderland

    Kirsten Smeets, MD

    Myrtille Vallen, MD PhD

    Not yet recruiting

  • Gelderse Vallei

    Ede, Gelderland

    Rahul Samlal, MD

    Lidewij Bartelink, MD PhD

    Recruiting

  • Catharina Hospital

    Eindhoven, North Brabant

    Dorry Boll, MD PhD

    Recruiting

  • St. Anna Hospital

    Geldrop, North Brabant

    Channa E Schmeink, MD PhD

    Recruiting

  • Elkerliek Hospital

    Helmond, North Brabant

    Joris van Esch, MD

    Recruiting

  • Radboudumc

    Nijmegen, Gelderland, 6525GA

    Hanny M.A. Pijnenborg, MD PhD, +31 024 361 1111, hanny.ma.pijnenborg@radboudumc.nl

    Ruben Koek, MD

    Recruiting

  • Canisius Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, Gelderland

    Willem Jan van Weelden, MD PhD

    Not yet recruiting

  • Elisabeth-Tweesteden Hospital

    Tilburg, North Brabant

    Marieke Smink, MD

    Recruiting

  • Bernhoven Hospital

    Uden, North Brabant

    Angèle Oei, MD

    Jos Vollenbergh, MD

    Recruiting

  • Maxima Medical Center

    Veldhoven, North Brabant

    Viola Verhoef, MD PhD

    Recruiting

  • Streekziekenhuis Koningin Beatrix

    Winterswijk, Gelderland

    Charlotte Lybol, MD PhD

    Lotte van Dijk, MD

    Not yet recruiting

Other trials in Netherlands

About this study

Official title: ENDORISK Clinical Implementation Study

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
Being tested
ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.
Keywords
ENDORISK, Endometrial Cancer, surgical staging, risk stratification, lymph node metastases, lymphadenectomy, sentinel node
Medical subject headings
Endometrial Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07200466
Study groupRoleWhat they receive
ControlNo interventionThe 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.
InterventionExperimentalThe 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.
Receives: Diagnostic Test: ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care.

    Measured: from enrolment to surgery

  2. 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.

    Measured: From enrolment to time of surgery

  3. 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

    Measured: From enrolment to 12 weeks post-operatively

Secondary outcomes (10)

  1. Patients' 5-year disease- specific-, overall survival (DSS, OS), compared to standard care;

    Measured: from enrolment to 5-year post surgery

  2. Health related quality of life (HRQoL) compared to standard care

    as measured by questionnaire: EORTC Quality of life questionnaire (QLQ) -C30

    Measured: 12 weeks after primary surgery

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

    as measured by questionnaire: EORTC QLQ-C30

    Measured: 12 months after primary surgery

  4. Treatment-related morbidity compared to standard care

    As measured by questionnaire: EORTC QLQ- Endometrial cancer (EN) 24

    Measured: 12 weeks after primary surgery

  5. 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)

    Measured: 12 months after primary surgery

  6. Clinicians' experiences with ENDORISK care

    Questionnaire at baseline

    Measured: at baseline

  7. Clinicians' experiences with ENDORISK care

    Questionnaire at 9 months

    Measured: 9 months after start of inclusions

  8. Clinicians' experiences with ENDORISK care

    Questionnaire at 18 months

    Measured: 18 months after start of inclusions

  9. Clinicians' experiences with ENDORISK care

    In depth interviews with a sample of participating clinicians to evaluate user experiences.

    Measured: Within 1 year of start of the inclusion period in their hospital.

  10. Impact of ENDORISK on regional care costs

    Measured: from enrolment to the end of inclusions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start23 Oct 2025
  3. Primary completion16 Oct 2027 (estimated)
  4. Study completion16 Oct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
735 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200466
Sponsor's protocol ID
NL86300.000.24
Other IDs
14032
Acronym
ENDORISK-I
Status last verified
Jul 2025
First submitted
23 Jul 2025
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35992828

  • 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.

    PubMed 32413043

  • 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.

    PubMed 35939115

Questions about this trial

What is this clinical trial studying?

A study testing ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer. in people with Endometrial Cancer, run by Radboud University Medical Center at 14 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruben C.G. Koek, MD / Drs (+31631015109, ruben.koek@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care. (time frame: from enrolment to surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07200466, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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