Personalized tool to predict lymph node spread in early endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rijnstate
  Arnhem, Gelderland, Netherlands Recruiting
• Gelderse Vallei
  Ede, Gelderland, Netherlands Recruiting
• Radboudumc
  Nijmegen, Gelderland, Netherlands Recruiting
• Jeroen Bosch Hospital
  's-Hertogenbosch, North Brabant, Netherlands Recruiting
• Amphia
  Breda, North Brabant, Netherlands Recruiting
• Catharina Hospital
  Eindhoven, North Brabant, Netherlands Recruiting

Study contacts

• Study coordinator: Ruben C.G. Koek, MD / Drs
• Email: ruben.koek@radboudumc.nl
• Phone: +31631015109

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.