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

NCT06279832 | Recruiting DMC

• 1 other identifier: 3994
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Endometrial Cancer

Keywords

Radiomic; Ultrasound; MRI; Molecular sequencing; Radiogenomic; Omic analyses; molecular classification

Outcome Measures

Primary Outcomes (1)

• Predictive value of the model

  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 Outcomes (1)

• Validity of the model

  up to one year

Study Arms (1)

Transcriptomic analyses

EXPERIMENTAL

Other: trascriptomic profiling

Interventions

trascriptomic profiling OTHER

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.

Transcriptomic analyses

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCSS

Rome, Lazio, 00118, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: As far as the sample size concerns, the number of images required for the analysis are a figure of at least 100 positive cases (15). We considered as positive patients with a favorable prognostic profile according to PORTEC-4a and also low and intermediate risk class according to ESGO/ESTRO/ESP 2020 recommendations.Therefore, we estimate to enroll at least 1000 patients in order to reach the 100 positive cases.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: February 28, 2024
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)