Endometrial CancerROMENCT06963385
Radiomics and Molecular Classification in Endometrial Cancer
A study testing Radiomics in people with Endometrial Cancer and Uterine Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Molecular/genomic profiling is the most accurate method to assess the prognosis of endometrial cancer patients. Interestingly, the adoption of radiomics showed important results, across various oncologic specialties. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Uterine Cancer, Endometrium Tumor
- What is being tested?
- Radiomics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- preoperative endometrial cancer (any histology); (ii) preoperative ultrasonographic examination; (iii) surgical treatment; (iv) age >= 18 years; (v) signed informed consent for research purposes.
Who cannot join
- consent withdraw; (ii) lack of available (tumor) tissue for molecular/genomic profiling.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, 20133
About this study
Official title: Correlation Between RadiOmics and Molecular Classification in Endometrial Cancer (the ROME Study): a Step Forward to a Simplified Precision Medicine
Molecular/genomic profiling is the most accurate method to assess the prognosis of endometrial cancer patients. Interestingly, the adoption of radiomics showed important results, across various oncologic specialties. Radiomic allows extracting mineable high-dimensional data from clinical images, thus providing a number of noteworthy information of the tumor tissues. We aim to correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk The central hypothesis is that combining radiomic features might allow identifying various classes of risk for endometrial cancer. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative, and cheap method for tailor operative and postoperative treatment modality in endometrial cancer.
- Conditions
- Endometrial Cancer, Uterine Cancer, Endometrium Tumor
- Being tested
- Radiomics
- Keywords
- radiomics, endometrial cancer, molecular/genetic profiling, radiogenomics, ultrasound
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiomicsDiagnostic test
To correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk
| Study group | Role | What they receive |
|---|---|---|
| Radiomics analysis and molecular/genomic profiling | Experimental | This prospective single-arm observational study. Patients with newly diagnosed endometrial cancer have an ultrasonographic evaluation and radiomic analysis of the ultrasonographic images. Then patients have surgery followed by molecular/genomic evaluation. We correlate radiomic features with molecular/genomic profiling. Receives: Diagnostic Test: Radiomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk.
Measured: 1-18 months
Determinate the scaled impact of radiomic features assessed on ultrasonographic images of endometrial tumors.
Measured: 1-36 months
Secondary outcomes (1)
Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors
Measured: 19-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start15 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Chiappa, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963385
- Sponsor's protocol ID
- Int140/20
- Acronym
- ROME
- Status last verified
- May 2025
- First submitted
- 1 Dec 2020
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between RadiOmics and Molecular Classification in Endometrial Cancer (the ROME Study): a Step Forward to a Simplified Precision Medicine
- ClinicalTrials.gov ID
- NCT06963385
- Acronym / sponsor ID
- ROME / Int140/20
- Conditions
- Endometrial Cancer, Uterine Cancer, Endometrium Tumor
- Keywords
- radiomics, endometrial cancer, molecular/genetic profiling, radiogenomics, ultrasound
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2025 (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.
Molecular/genomic profiling is the most accurate method to assess the prognosis of endometrial cancer patients. Interestingly, the adoption of radiomics showed important results, across various oncologic specialties. Radiomic allows extracting mineable high-dimensional data from clinical images, thus providing a number of noteworthy information of the tumor tissues. We aim to correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk The central hypothesis is that combining radiomic features might allow identifying various classes of risk for endometrial cancer. The rationale for the proposed research is that once validated, radiomics applied to ultrasonographic images would be an effective, innovative, and cheap method for tailor operative and postoperative treatment modality in endometrial cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiomics analysis and molecular/genomic profiling | Experimental | Diagnostic Test: RadiomicsThis prospective single-arm observational study. Patients with newly diagnosed endometrial cancer have an ultrasonographic evaluation and radiomic analysis of the ultrasonographic images. Then patients have surgery followed by molecular/genomic evaluation. We correlate radiomic features with molecular/genomic profiling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- preoperative endometrial cancer (any histology); (ii) preoperative ultrasonographic examination; (iii) surgical treatment; (iv) age >= 18 years; (v) signed informed consent for research purposes.
Key exclusion criteria (1 listed)
- consent withdraw; (ii) lack of available (tumor) tissue for molecular/genomic profiling.
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 |
|---|---|---|
| RadiomicsTo correlate radiomic features obtained from ultrasound images with the molecular/genomic profiling to identify new hallmarks for stratification of endometrial cancer patients into different classes of risk | Diagnostic test | Radiomics analysis and molecular/genomic profiling |
Primary outcome
To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk.
Time frame: 1-18 months
Determinate the scaled impact of radiomic features assessed on ultrasonographic images of endometrial tumors.
Time frame: 1-36 months
1 secondary outcome
Assess the intraobserver and interobserver reproducibility of radiomic features on ultrasonographic images of endometrial tumors
Time frame: 19-36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiomics in people with Endometrial Cancer and Uterine Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detail the mechanism by which radiomic features predict the classification of endometrial cancer into various classes of risk. (time frame: 1-18 months). The study lists 2 primary outcomes in all. 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 9 May 2025.