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Recruiting NCT05793333

Predictors of Node Positivity in Endometrial Cancer

Observational Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Endometrial Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study

Overview

To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.

Primary outcome measures

  • positive nodes [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Written informed consent
  • Histologically confirmed endometrila cancer
  • Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)
  • Data on histological characteristics of the ttumor
  • Execution of sentinel node mapping
  • Data on sentinel node status (negative vs. positive)

Exclusion criteria

  • Stage IVB endoemtrial cancer
  • consent withdraw

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione IRCCS Istituto Nazionale dei Tumori — Milan

Publications

  • Bogani G, Lalli L, Casarin J, Ghezzi F, Chiappa V, Fanfani F, Scambia G, Raspagliesi F. Predicting the Risk of nOdal disease with histological and Molecular features in Endometrial cancer: the prospective PROME trial. Int J Gynecol Cancer. 2024 Sep 2;34(9):1366-1372. doi: 10.1136/ijgc-2024-005416. PMID 38658017

Identifiers

NCT: NCT05793333 · 142020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗