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Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.

NCT06279832 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-02-28

No results posted yet for this study

Summary

The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).

These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.

Conditions

Interventions

OTHER

trascriptomic profiling

The mutational and copy number analyses will be complemented by transcriptomic profiling. RNA will be extracted from FFPE samples using miRNAeasy FFPE kit (Qiagen) and checked for quality and quantify by 2100 Bioanalyzer instrument (Agilent) and Qubit Fluorometer (ThermoFisher), respectively. Transcriptome analyses will be performed by RNA-seq. We will apply total RNAseq using the Illumina® TruSeq Stranded Total RNA workflow that provides a solution allowing the detection of whole transcriptome, splicing variants, and transcript fusions of human RNA isolated from FFPE samples. Libraries will be run using the Illumina's Novaseq6000 system, with a least 50 millions of reads/sample, the minimum read depth for the correct evaluation of low expressed transcripts.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-10-31
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279832 on ClinicalTrials.gov