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NCT04845425 Clinical Trial

Analysis of miRNA Expression in Endometrial Cancer

Endometrial Cancer Clinical Trial

— MIRCE  

Official title:
Identification of miRNAs in Endometrial Cancer as Novel Diagnostic and Prognostic Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04845425
Other study ID # 189/2021/Oss/AOUBo
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date December 2022

Study information
Verified date July 2022
Source IRCCS Azienda Ospedaliero-Universitaria di Bologna
Contact Anna Myriam Perrone, MD
Phone +39-3498359048
Email myriam.perrone@aosp.bo.it,
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS- Azienda Ospedaliera-Universitaria di Bologna Bologna Bo

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of miRNA expression based on the 4 molecular groups Evaluate miRNA expression based on the 4 molecular groups recently identified 1 year
Secondary Integration of molecular results with clinico-pathological data Integration of molecular results with clinico-pathological data 1 year
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