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

Endometrial Cancer Clinical Trial

— Romantic  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279832
• Other study ID #: 3994
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli IRCSS	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Validity of the model	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