Analysis of miRNA Expression in Endometrial Cancer

• Conditions: Endometrial Cancer

• Registration Number: NCT04845425
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Study First Posted: 2021-04-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-21
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Integration of molecular results with clinico-pathological data	1 year	Integration of molecular results with clinico-pathological data

Trial Locations

Locations (1)

IRCCS- Azienda Ospedaliera-Universitaria di Bologna; 🇮🇹 Bologna, Bo, Italy