Radiomic MRI model to predict response to chemoradiotherapy in locally advanced cervical cancer
Developing a Radiomic MRI Model Predictive of Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer. A Prognostic, Retrospective, Open-label, Multicenter, Descriptive and Analytical Clinical Cohort Study
This project tests whether MRI-based radiomic features can predict how women with locally advanced cervical cancer will respond to combined chemotherapy and radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nîmes, Gard) |
| Trial ID | NCT07305727 on ClinicalTrials.gov |
What this trial studies
Researchers will use the EPICOL clinical-biological cohort of patients treated with definitive concomitant chemoradiotherapy to develop a predictive model from radiomic features extracted from pelvic MRIs taken before and after treatment. The cohort includes 136 patients treated at Montpellier Cancer Institute and Nîmes University Hospital with at least two years of follow-up and available biopsy tissue. Imaging features will be correlated with outcomes such as recurrence-free survival and locoregional failure, and models will be trained and internally validated to identify patterns associated with poor or good response. The aim is to validate existing radiomic approaches and determine whether they can be applied in routine care.
Who should consider this trial
Good fit: Women with locally advanced cervical cancer who received definitive concomitant chemoradiotherapy and have pre- and post-treatment pelvic MRIs, available initial biopsy tissue, and at least two years of follow-up are the intended candidates.
Not a fit: Patients without usable MRI scans or initial biopsy specimens, those who received different treatment approaches, or those under legal guardianship are unlikely to benefit from this research.
Why it matters
Potential benefit: If successful, the model could identify patients unlikely to respond to standard chemoradiotherapy so clinicians can consider alternative or intensified treatments earlier.
How similar studies have performed: A few prior small studies have shown that radiomic MRI features may predict recurrence or survival in locally advanced cervical cancer, but those models need further exploration and validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients treated with exclusive radio-chemotherapy for locally advanced cervical cancer (stage Ib-IVb according to the FIGO classification). * Patients with a minimum of 2 years of post-treatment follow-up. * Patients for whom the initial biopsy specimen (prior to treatment) is available. * Patients who have not expressed their opposition to participating in the study. * Patients who are affiliated with or beneficiaries of a health insurance plan. Exclusion Criteria: * Patients under judicial protection, guardianship, or curatorship
Where this trial is running
Nîmes, Gard
- Nimes University Hospital — Nîmes, Gard, France (Recruiting)
Study contacts
- Study coordinator: Frédéric FITENI, Professor
- Email: frederic.fiteni@chu-nimes.fr
- Phone: +334.34.03.46.69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.