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US Radiomics in Advanced Cervical Cancer

NCT06984289CompletedOBSERVATIONAL

Summary

This is a retrospective, multicenter observational study aimed at evaluating the role of ultrasound-based radiomics in patients with locally advanced cervical cancer (LACC). The study will analyze pre-treatment ultrasound images to identify radiomic features that may predict treatment response and disease recurrence. A total of 220 patients treated with exclusive chemoradiotherapy or neoadjuvant chemoradiotherapy followed by radical surgery between 2011 and 2024 will be included. Using clinical and imaging data, machine learning models will be developed to distinguish between responders and non-responders, and to identify patients at higher risk of relapse. The goal is to improve personalized care in LACC by integrating radiomic analysis into treatment planning and follow-up strategies.

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

220

Start Date

2025-03-25

Completion Date

2025-04-30

Study Type

OBSERVATIONAL

Official Title

Role of Radiomics Applied to Ultrasound in Patients With Locally Advanced Cervical Cancer: a Retrospective Multicenter Study

Interventions

Radiomic Analysis of Ultrasound Images

Conditions

Uterine Cervical NeoplasmsLocally Advanced Cervical CancerRadiomicsUltrasound ImagingMachine LearningChemoradiotherapy

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

Female patients aged ≥18 years

Histologically confirmed diagnosis of locally advanced cervical cancer (FIGO 2018 stage IB3-IVA, excluding IIA1)

Histologic subtypes: squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

Underwent transvaginal or transrectal ultrasound prior to treatment

At least one pre-treatment DICOM ultrasound image of the primary tumor available

Treated with either exclusive chemoradiotherapy or neoadjuvant chemoradiotherapy followed by radical surgery

Completed at least 12 months of follow-up after primary treatment

Signed informed consent (or equivalent declaration)

Exclusion Criteria:

Age \<18 years

Only printed ultrasound images available

Ultrasound images with poor tumor visualization or with text/markers obscuring the tumor

Outcome Measures

Primary Outcomes

Performance of ultrasound-based radiomic models in predicting treatment response in patients with locally advanced cervical cancer.

Evaluation of the diagnostic accuracy (AUC, sensitivity, specificity, F1-score) of radiomic models based on pre-treatment ultrasound images in distinguishing responder vs. non-responder patients to primary treatment (exclusive chemoradiotherapy or neoadjuvant chemoradiotherapy followed by radical surgery). Models will be developed and validated using retrospective data.

Time frame: Up to 12 months after primary treatment.

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy