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.
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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria
Bologna, Bologna, 40138
Anna Myriam Perrone, MD, 051 2144368, myriam.perrone@unibo.it
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 .
- Conditions
- Uterine Sarcoma, Uterine Myoma
- 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.
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)
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.
- First posted3 Feb 2025
- Study start7 Nov 2022
- Primary completion1 Mar 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine SarcomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Model for the Differential Diagnosis of SArcoma/myoma Based on the RAdiomics Features: Single-center Observational Study
- ClinicalTrials.gov ID
- NCT06805019
- Acronym / sponsor ID
- SARA / 589/2022/Oss/AOUBo
- Conditions
- Uterine Sarcoma, Uterine Myoma
- Keywords
- uterine sarcoma, uterine myoma, radiomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Feb 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.
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.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ROC analysis parameters
Time frame: 6 months
Sensitivity, specificity, PPV, NPV, AUC of the classifier (radiomics model) compared to the gold standard (histological report) to discriminate between myoma and sarcoma.
1 secondary outcome
ROC analysis parameters
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
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.