NCT04845425

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

April 10, 2021

Last Update Submit

July 19, 2022

Conditions

Keywords

endometrial cancermiRNAmicroRNATGCA

Outcome Measures

Primary Outcomes (1)

  • Evaluation of miRNA expression based on the 4 molecular groups

    Evaluate miRNA expression based on the 4 molecular groups recently identified

    1 year

Secondary Outcomes (1)

  • Integration of molecular results with clinico-pathological data

    1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with endometrial cancer

You may qualify if:

  • age\>18yo
  • histological diagnosis of endometrial cancer
  • tumor resection
  • patient's informed consent

You may not qualify if:

  • patients with other neoplasia within the last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS- Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bo, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Anna Myriam Perrone

    IRCCS Azienda Ospedaliera-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Myriam Perrone, MD

CONTACT

Anna Myriam Perrone

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 15, 2021

Study Start

April 1, 2021

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations