A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

Cervical cancer is the fourth most common cancer in women worldwide, with approximately 604,000 new cases in 2020.Treatment for locally advanced cervical cancer is based on a combination of radiotherapy and chemotherapy. The response to concomitant chemoradiotherapy vary from one woman to another. Predicting the response to these treatments would allow early consideration of alternative therapies for patients identified as less responsive to standard treatments. A 5-year recurrence-free survival is approximately 79% for stages IB and IIA and 59% for stages III and IVA, with approximately 36% of local failures despite chemoradiotherapy. In a few studies,the radiomic MRI approach in locally advanced cervical cancers has shown to be prognostic for locoregional recurrence or survival but these models still need to be explored and validated.The EPICOL cohort, a clinical-biological cohort of 136 patients treated with chemoradiotherapy for locally advanced cervical cancer at the Montpellier Cancer Institute or Nîmes University Hospital, will be used to develop a predictive model of response to chemoradiotherapy based on radiomic data from pelvic MRIs before and after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients under judicial protection, guardianship, or curatorship

Trial population

For this study, data from 120 patients for whom we have MRI data from the EPICOL cohort (136 patients included) will be used.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Prognostic role of a magnetic resonance imaging radiomic model on progression-free survival in patients treated for locally advanced cervical cancer.

Time from diagnosis to death from any cause or progression (according to RECIST v1.1 criteria) at 24 months of follow-up.

Time frame
Month 24

Secondary outcomes

1

Prognostic role of an magnetic resonance imaging radiomic model on overall survival in patients treated for locally advanced cervical cancer.

Time between treatment initiation and death from any cause at 24 months of follow-up.

Time frame
Month 24
2

Correlation between the radiomic magnetic imaging radiomic model and Programmed cell Death protein 1 (PD-L1) expression.

Collection of Programmed cell Death protein 1 (PD-L1) expression levels from biopsies from the EPICOL cohort.

Time frame
Month 24
3

Correlation between the radiomic magnetic resonance imaging model and tumor-infiltrating lymphocytes (TILs).

Collection of tumor-infiltrating lymphocyte (TIL) expression levels in biopsies from the EPICOL cohort.

Time frame
Month 24

Other outcomes

Sponsors and contacts

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