Actively Recruiting
Construction of a Model for the Differential Diagnosis of SArcoma/myoma Based on the RAdiomics Features: Single-center Observational Study
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-03
176
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying uterine sarcomas and uterine myomas to improve diagnosis before surgery. Uterine sarcomas are rare and aggressive tumors with a high risk of recurrence and death, while uterine myomas are common benign tumors that may require treatment if symptomatic. Current imaging methods like MRI and CT have limitations in distinguishing these two conditions preoperatively, and accurate diagnosis usually happens after surgery with histological examination. This study explores using radiomics, a technique that extracts detailed data from CT images, to help differentiate between sarcoma and myoma before surgery and guide personalized treatment decisions. The study involves analyzing CT scans taken within 30 days before surgery from patients diagnosed with either uterine sarcoma or myoma. Radiomics features will be extracted from these images to develop a model for differential diagnosis. Patients are followed according to the clinical care pathway at the study center, and informed consent is obtained. No new treatments or interventions are administered as this is an observational study focusing on imaging data analysis. Participants will have preoperative CT scans evaluated for quality and diagnostic features. Researchers will perform ROC analysis to assess how well the radiomics model can distinguish between sarcomas and myomas. Data will be collected and analyzed over six months to measure diagnostic accuracy. The study does not involve additional procedures beyond routine imaging and clinical follow-up, and patients continue their usual care during and after the study period.
CONDITIONS
Brief Title
Construction of a Model for the Differential Diagnosis of SArcoma/myoma Based on the RAdiomics Features: Single-center Observational Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of uterine sarcoma or myoma
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants undergo pre-operative CT scans performed for diagnostic suspicion within 30 days before surgery.
1 visit (in-person)
Duration - 6 months
Participants are followed for up to 6 months to assess diagnostic outcomes and clinical care.
Follow-up visits as per clinical care path
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
A
Anna Myriam Perrone, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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