US Radiomics in Advanced Cervical Cancer (RU-LACC)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Uterine Cervical Neoplasms; Ultrasound Imaging; Machine Learning; Radiomics; Chemoradiotherapy; Locally Advanced Cervical Cancer

Treatments: Other: Radiomic Analysis of Ultrasound Images

Study type: Observational

Funder types: Other

Identifiers

NCT06984289

7443

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

220 participants in 2 patient groups

Responder Group

Description:

Patients with locally advanced cervical cancer who responded to primary treatment (either exclusive chemoradiotherapy or neoadjuvant chemoradiotherapy followed by radical surgery), as determined by clinical and/or histological assessment.

Treatment:

Other: Radiomic Analysis of Ultrasound Images

Non-Responder Group

Description:

Patients with locally advanced cervical cancer who did not respond to primary treatment (either exclusive chemoradiotherapy or neoadjuvant chemoradiotherapy followed by radical surgery), based on residual disease findings or lack of clinical response.

Treatment:

Other: Radiomic Analysis of Ultrasound Images