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MIRCE: Analysis of miRNA Expression in Endometrial Cancer

Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
Overall Status
Recruiting
CT.gov ID
NCT04845425
Collaborator
(none)
150
Enrollment
1
Location
20
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP carcinomas present a wide variability in molecular alterations and biological aggressiveness. Given that the study aims to evaluate the miRNA expression profile to identify novel potential biomarkers to better stratify the EC patients, taking into account the molecular status

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Identification of miRNAs in Endometrial Cancer as Novel Diagnostic and Prognostic Biomarkers
    Actual Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of miRNA expression based on the 4 molecular groups [1 year]

      Evaluate miRNA expression based on the 4 molecular groups recently identified

    Secondary Outcome Measures

    1. Integration of molecular results with clinico-pathological data [1 year]

      Integration of molecular results with clinico-pathological data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age>18yo

    • histological diagnosis of endometrial cancer

    • tumor resection

    • patient's informed consent

    Exclusion Criteria:
    • patients with other neoplasia within the last 5 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS- Azienda Ospedaliera-Universitaria di Bologna Bologna Bo Italy 40138

    Sponsors and Collaborators

    • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Investigators

    • Principal Investigator: Anna Myriam Perrone, IRCCS- Azienda Ospedaliera-Universitaria di Bologna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Myriam Perrone, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
    ClinicalTrials.gov Identifier:
    NCT04845425
    Other Study ID Numbers:
    • 189/2021/Oss/AOUBo
    First Posted:
    Apr 15, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anna Myriam Perrone, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
    endometrial cancer
    miRNA
    microRNA
    TGCA
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Jul 21, 2022