Endometrial CancerRomanticNCT06279832
Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer.
A study testing trascriptomic profiling in people with Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- trascriptomic profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Clinical information not available or incomplete
- Any other malignancy in the previous 5 years or synchronous
- Patients aged under 18 years
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli IRCSS
Rome, Lazio, 00118
francesco fanfani, 0630151, francesco.fanfani@policlinicogemelli.it
About this study
Official title: 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.
- Conditions
- Endometrial Cancer
- Being tested
- trascriptomic profiling
- Keywords
- Radiomic, Ultrasound, MRI, Molecular sequencing, Radiogenomic, Omic analyses, molecular classification
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trascriptomic profilingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcriptomic analyses | Experimental | Not described Receives: Other: trascriptomic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one year
Secondary outcomes (1)
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
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanfani Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279832
- Sponsor's protocol ID
- 3994
- Acronym
- Romantic
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer ID: ROMANTIC STUDY
- ClinicalTrials.gov ID
- NCT06279832
- Acronym / sponsor ID
- Romantic / 3994
- Conditions
- Endometrial Cancer
- Keywords
- Radiomic, Ultrasound, MRI, Molecular sequencing, Radiogenomic, Omic analyses, molecular classification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transcriptomic analyses | Experimental | Other: trascriptomic profiling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trascriptomic profilingThe 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. | Other | Transcriptomic analyses |
Primary outcome
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.
1 secondary outcome
Validity of the model
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fondazione Policlinico Agostino Gemelli IRCSS
Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trascriptomic profiling in people with Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of the model (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.