Personalized tool to predict lymph node spread in early endometrial cancer
ENDORISK Clinical Implementation Study
This study will test whether using the ENDORISK risk model helps doctors better predict lymph node spread before surgery for people with early-stage endometrial cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 735 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 14 sites (Arnhem, Gelderland and 13 other locations) |
| Trial ID | NCT07200466 on ClinicalTrials.gov |
What this trial studies
ENDORISK is a Bayesian network model developed to predict preoperative risk of lymph node metastasis in endometrial cancer and has been validated in three external cohorts. This implementation uses a stepped-wedge, non-inferiority design in which two oncology regions start using the model one year apart and clinicians complete the model during preoperative treatment counseling. Outcomes after implementation will be compared to prospectively collected standard-care data to see whether routine use changes risk stratification and surgical decision-making. Eligible patients are those with FIGO stage I–II endometrial carcinoma who are planned for primary surgical treatment.
Who should consider this trial
Good fit: People with early-stage (FIGO I–II) endometrial carcinoma who are eligible for primary surgery, can give informed consent, and understand Dutch or English.
Not a fit: Patients with rare endometrial sarcomas, advanced-stage disease, those unable to consent, or who cannot communicate in Dutch or English are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, ENDORISK could reduce unnecessary lymph node surgeries and help tailor surgical staging to each patient's actual risk.
How similar studies have performed: The ENDORISK model has been developed and validated with good performance in three external cohorts, but prospective implementation in routine care is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Arnhem, Gelderland and 13 other locations
- 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, 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)
Study contacts
- Study coordinator: Ruben C.G. Koek, MD / Drs
- Email: ruben.koek@radboudumc.nl
- Phone: +31631015109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.