Clinical trial NCT06984289: US Radiomics in Advanced Cervical Cancer
Official title: Role of Radiomics Applied to Ultrasound in Patients With Locally Advanced Cervical Cancer: a Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Neoplasms
Locally Advanced Cervical Cancer
Radiomics
Ultrasound Imaging
Machine Learning
Chemoradiotherapy
Keywords: Locally Advanced Cervical Cancer
Cervical Cancer
Uterine Cervical Neoplasms
Radiomics
Ultrasound
Ultrasound Imaging
Machine Learning
Gynecologic Oncology
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced cervical cancer (FIGO 2018 IB3-IVA, excluding IIA1), treated between 2011 and 2024, from multiple Italian centers. All participants underwent ultrasound before treatment and have available DICOM images for radiomic analysis.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance of ultrasound-based radiomic models in predicting treatment response in patients with locally advanced cervical cancer.
timeFrame: Up to 12 months after primary treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli
name: Camilla Culcasi
role: STUDY_CHAIR
References: