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Uterine SarcomaSARANCT06805019

Construction of a Model for the Differential Diagnosis of SArcoma/myoma Based on the RAdiomics Features: Single-center Observational Study

An observational study of Uterine Sarcoma and Uterine Myoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Uterine sarcomas are rare and aggressive tumors originating from the muscular wall of the uterus. They have a high risk of recurrence and death, regardless of the stage of the disease at diagnosis. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Uterine Sarcoma, Uterine Myoma
How many people
176 participants
Where
1 siteItaly
Study dates
7 Nov 2022to 30 Jun 2025
Phase
Observational
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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with sarcoma belonging to the Gynecological Oncology Center of the IRCCS University Hospital of Bologna (study group) from 10/1/2007 to 09/30/2021 and followed in follow-up for up to one year. Patients affected by uterine myomas who have undergone hysterectomy will be selected as a comparison group.

Who may be able to join

  • Histological diagnosis of uterine sarcoma or myoma
  • Patients with pre-operative CT performed for diagnostic suspicion no more than 30 days before surgery
  • Age between 18 and 80 years
  • Patients followed in the clinical care path in our center
  • Obtaining informed consent

Who cannot join

  • Low quality of CT images.
  • Patients affected by other active neoplasms or diagnosed less than 5 years before the diagnosis of uterine sarcoma or myoma.

Trial locations and contacts

1 site in 1 country.

Anna Myriam Perrone, MD contact

051 2144368

myriam.perrone@unibo.it

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria

    Bologna, Bologna, 40138

    Anna Myriam Perrone, MD, 051 2144368, myriam.perrone@unibo.it

    Recruiting

Other trials in Italy

About this study

Uterine sarcomas are rare and aggressive tumors originating from the muscular wall of the uterus. They have a high risk of recurrence and death, regardless of the stage of the disease at diagnosis. The therapy is surgical and involves hysterectomy preferably via laparotomy in consideration of the high risk of neoplastic dissemination through the rupture and fragmentation of the neoplasm as occurs through removal by other surgical routes which involve core drilling of the mass (laparoscopic, vaginal , hysteroscopic).

Uterine myoma represents a very frequent benign pathology in women, with an incidence of approximately 70%-80%. Asymptomatic cases do not require treatment, while symptomatic cases can be treated through the administration of generally antiestrogenic drugs to block growth and symptoms. Only a small part is removed surgically.

Read more

Currently the diagnosis of uterine sarcoma is almost always defined in the post-operative setting with the definitive histological examination, due to the lack of typical sonographic and radiological characteristics of certainty capable of differentiating benign neoplastic forms (myoma) from malignant ones of the uterus (sarcoma).

Magnetic resonance imaging is currently the most reliable imaging modality for characterizing such uterine masses. Unfortunately, although it offers useful information, it is not able to discriminate with good precision a benign uterine lesion from a malignant one.

CT is a method widely used in the staging of oncological diseases and therefore also in sarcomas. It is usually prescribed when there is an ultrasound doubt of a sarcoma before proceeding with surgery.

However, although it is important in the definition of secondaries, it has very low sensitivity (60%) and specificity in the differential diagnosis between sarcoma and myoma.

Radiomics is a novel approach that translates medical images into data by extracting a large number of quantitative features describing tissue characteristics, shape and texture, combining quantitative data analysis with biological and clinical endpoint.

Capturing information from imaging that goes beyond the different biomedical imaging formats themselves is the great promise of this growing field.

The application of radiomics analysis to CT with the aim of preoperatively discriminating between sarcoma (malignant) and myoma (benign) could be a valid support in the preoperative evaluation and therapeutic decision-making process in order to personalize the most appropriate therapeutic approach .

Keywords
uterine sarcoma, uterine myoma, radiomic
Medical subject headings
Myofibroma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ROC analysis parameters

    Sensitivity, specificity, PPV, NPV, AUC of the classifier (radiomics model) compared to the gold standard (histological report) to discriminate between myoma and sarcoma.

    Measured: 6 months

Secondary outcomes (1)
  1. ROC analysis parameters

    Sensitivity, specificity, PPV, NPV, AUC of the classifier (radiomics model) to discriminate between aggressive sarcomas that have relapsed and sarcomas that have not relapsed in the first year of follow up.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start7 Nov 2022
  3. Primary completion1 Mar 2024
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06805019
Sponsor's protocol ID
589/2022/Oss/AOUBo
Acronym
SARA
Status last verified
Sep 2024
First submitted
28 Jan 2025
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Uterine Sarcoma and Uterine Myoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 5 inclusion and 2 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 3 Feb 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Myriam Perrone, MD (051 2144368, myriam.perrone@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ROC analysis parameters (time frame: 6 months). 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 3 Feb 2025.

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