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

February 19, 2024 updated by: Fanfani Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer ID: ROMANTIC STUDY

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pathologically confirmed diagnosis of primary endometrial cancer (endometrioid, clear cell, serous, mixed, any grade)
  • FIGO stage IA-IB
  • Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis available - Availability of preoperative MRI scans in dicom (.dcm) format
  • Availability of preoperative US images in dicom (.dcm) format
  • Availability of preoperative CT-scan images in dicom (.dcm) format (optional)
  • Available clinical information (e.g. baseline information, surgery, adjuvant therapy, median follow up period 24 months)

Exclusion Criteria:

  • Metastatic cancer to the uterus (not primary EC)
  • Uterine sarcoma
  • Conservative surgery
  • FIGO stage > II
  • Formalin-fixed, paraffin-embedded (FFPE) tissue at the diagnosis not available
  • Patients without available MRI, US or CT-scan images on digital media
  • Clinical information not available or incomplete
  • Any other malignancy in the previous 5 years or synchronous
  • Patients aged under 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcriptomic analyses
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of the model
Time Frame: up to one year
Receiver operating characteristic (ROC) curve and 95% confidence interval (CI) will be performed to determine cut-off values for the studied quantitative variables.
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of the model
Time Frame: up to one year
To test the validity of different clinical and ultrasound variables Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be determined
up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3994

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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