Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.
NCT ID: NCT06279832
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2023-11-01
2025-10-31
Brief Summary
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These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Transcriptomic analyses
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Fanfani Francesco
Professor
Locations
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Fondazione Policlinico Agostino Gemelli IRCSS
Rome, Lazio, Italy
Countries
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Facility Contacts
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Other Identifiers
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3994
Identifier Type: -
Identifier Source: org_study_id
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