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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

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