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RecruitingNCT06805019SARAUpdated Feb 3, 2025

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

An observational study in Uterine Sarcoma and Uterine Myoma, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
176
Ages
18 Years to 80 Years
Sex
Female
01

Study 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. 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 .

02

Conditions studied

  • Uterine Sarcoma
  • Uterine Myoma

Keywords

  • uterine sarcoma
  • uterine myoma
  • radiomic
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
176 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • IRCCS Azienda Ospedaliero-Universitaria
    Bologna, 40138, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06805019
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Feb 3, 2025
Start date
Nov 7, 2022
Primary completion
Mar 1, 2024
Completion
Jun 30, 2025 (estimated)
Last update
Feb 3, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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