Predictors of Node Positivity in Endometrial Cancer

September 15, 2024 updated by: Valentina Chiappa, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patietns were submitted to standard treatment modality for managing endometrial cancer. They will receive hsyterectomy (with or without bilateral salpingo-oophorectomy) plus sentinel ndoe mapping.

After the procedures data regarding hystologcial charactersitcs of the tumor and molecular features will be analyzed (as routine cliical practice).

We will correlate those data with findings achieved by sentinel nodes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive nodes
Time Frame: 12 months
positive nodes detected by sentinel node mappinig
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Study Chair: Giorgio Bogani, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

March 4, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 142020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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