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Predictors of Node Positivity in Endometrial Cancer

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05793333
Collaborator
(none)
100
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. positive nodes [12 months]

      positive nodes detected by sentinel node mappinig

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Valentina Chiappa, Dr, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    ClinicalTrials.gov Identifier:
    NCT05793333
    Other Study ID Numbers:
    • 142020
    First Posted:
    Mar 31, 2023
    Last Update Posted:
    Mar 31, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Valentina Chiappa, Dr, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    sentinel node
    endometrial cancer
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Mar 31, 2023