Uterine Cervical NeoplasmsRU-LACCNCT06984289
US Radiomics in Advanced Cervical Cancer
An observational study of Uterine Cervical Neoplasms and Locally Advanced Cervical Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Locally Advanced Cervical Cancer, Radiomics
- What is being tested?
- Radiomic Analysis of Ultrasound Images
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2025to 14 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Age <18 years
- Only printed ultrasound images available
- Ultrasound images with poor tumor visualization or with text/markers obscuring the tumor
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
Official title: Role of Radiomics Applied to Ultrasound in Patients With Locally Advanced Cervical Cancer: a Retrospective Multicenter Study
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.
- Conditions
- Uterine Cervical Neoplasms, Locally Advanced Cervical Cancer, Radiomics, Ultrasound Imaging, Machine Learning, Chemoradiotherapy
- Being tested
- Radiomic Analysis of Ultrasound Images
- Keywords
- Locally Advanced Cervical Cancer, Cervical Cancer, Uterine Cervical Neoplasms, Radiomics, Ultrasound, Ultrasound Imaging, Machine Learning, Gynecologic Oncology
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomic Analysis of Ultrasound ImagesOther
Also called Radiomics, Ultrasound-based Radiomics, Radiomic Feature Extraction
Quantitative analysis of pre-treatment ultrasound images of the primary cervical tumor to extract radiomic features. These features will be used to develop and validate machine learning models for predicting treatment response and disease relapse in patients with locally advanced cervical cancer (LACC).
| Study group | Role | What they receive |
|---|---|---|
| Responder Group | 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. Receives: Other: Radiomic Analysis of Ultrasound Images | |
| Non-Responder Group | 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. Receives: Other: Radiomic Analysis of Ultrasound Images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after primary treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start25 Mar 2025
- Primary completion30 Apr 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilla Culcasi, Study chair, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984289
- Sponsor's protocol ID
- 7443
- Acronym
- RU-LACC
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Radiomics Applied to Ultrasound in Patients With Locally Advanced Cervical Cancer: a Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06984289
- Acronym / sponsor ID
- RU-LACC / 7443
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responder Group | – | Other: Radiomic Analysis of Ultrasound ImagesPatients 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. |
| Non-Responder Group | – | Other: Radiomic Analysis of Ultrasound ImagesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Age <18 years
- Only printed ultrasound images available
- Ultrasound images with poor tumor visualization or with text/markers obscuring the tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiomic Analysis of Ultrasound ImagesAlso: Radiomics, Ultrasound-based Radiomics, Radiomic Feature ExtractionQuantitative analysis of pre-treatment ultrasound images of the primary cervical tumor to extract radiomic features. These features will be used to develop and validate machine learning models for predicting treatment response and disease relapse in patients with locally advanced cervical cancer (LACC). | Other | Non-Responder Group, Responder Group |
Primary outcome
Performance of ultrasound-based radiomic models in predicting treatment response in patients with locally advanced cervical cancer.
Time frame: Up to 12 months after primary treatment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Culcasi study chair
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms and Locally Advanced Cervical Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of ultrasound-based radiomic models in predicting treatment response in patients with locally advanced cervical cancer. (time frame: Up to 12 months after primary treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.