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Trial Title:
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.
NCT ID:
NCT06279832
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
Radiomic
Ultrasound
MRI
Molecular sequencing
Radiogenomic
Omic analyses
molecular classification
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
trascriptomic profiling
Description:
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.
Arm group label:
Transcriptomic analyses
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fondazione Policlinico Agostino Gemelli IRCSS
Address:
City:
Rome
Zip:
00118
Country:
Italy
Status:
Recruiting
Contact:
Last name:
francesco fanfani
Phone:
0630151
Email:
francesco.fanfani@policlinicogemelli.it
Start date:
November 1, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279832
