Prognosis and Therapy Clues in High-Risk, Non-Invasive 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

This multicenter retrospective study collects anonymized data from patients diagnosed between 2010 and 2025 to determine lymph node involvement, recurrence rates, progression-free survival, and overall survival in non-myoinvasive endometrial cancer with high-risk molecular profiles (p53-abnormal, high-grade NSMP, and ER-negative NSMP). Participating centers will provide data via a standardized REDCap database, focusing on nodal staging methods and adjuvant therapies. The analysis will compare oncological outcomes across molecular subgroups and treatment strategies to identify potential prognostic signals. POLE status is not mandatory, but MMR and p53 status must be documented per ESGO criteria. This work aims to inform future risk stratification and treatment decisions in a rare clinical scenario.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients over 18 years old.
2. Patients with:

   2.1. p53-abnormal (p53-abn) endometrial carcinoma. 2.2. ER-negative NSMP tumours. 2.3. High-grade NSMP tumours. POLE mutations assessment is not mandatory. MMR and p53 status is mandatory, according to ESGO criteria.

   In whom:
   * No myometrial invasion is present in the final surgical specimen (nor cervical or adnexal invasion).
   * Tumours are identified by endometrial biopsy or hysteroscopic polypectomy with no residual tumour in the final surgical specimen (these cases will also be considered tumours without myometrial invasion).
3. Patients who underwent nodal staging, either with pelvic sentinel lymph node biopsy, associated with pelvic and/or para-aortic lymphadenectomy, or staged by lymphadenectomy alone.

3.1. To assess the rate of lymph node involvement, we will analyze tumors with the previous molecular characteristics mentioned and no myometrial invasion, regardless of whether lymph node involvement is present. Stage IIIC tumours will not be excluded; cases will be selected based on the absence of myometrial infiltration in the final pathology specimen. 3.2. On the other hand, for the survival statistical analyses, only patients with a final stage IC (FIGO 2023) will be included.

Exclusion Criteria:

Patients who do not meet the above inclusion criteria and who additionally present with the following conditions will be excluded:

1. Molecular profile not available.
2. Absence of nodal staging (sentinel lymph node biopsy or lymphadenectomy)
3. Inadequate follow-up.
4. Mismatch repair-deficient tumors.
5. POLE-ultramutated tumors, when identified.
6. Incomplete information regarding adjuvant treatment.
7. Presence of myometrial invasion.

Where it's running

• Hospital Universitari Vall d'Hebron
  Barcelona, Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Ana A Luzarraga Aznar, MD PhD — Hospital Universitari Vall d'Hebron Research Institute
• Study coordinator: Ana A Luzarraga Aznar, MD, PhD
• Email: ana.luzarraga@vallhebron.cat
• Phone: +34665644810

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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.