Uterine Cervical NeoplasmsEPICOL-RNCT07305727
A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer
An observational study of Uterine Cervical Neoplasms and Cervical Cancer by FIGO Stage 2018, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Cervical Cancer by FIGO Stage 2018
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: For this study, data from 120 patients for whom we have MRI data from the EPICOL cohort (136 patients included) will be used.
Who may be able to join
- 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.
Who cannot join
- Patients under judicial protection, guardianship, or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nimes University Hospital
Nîmes, Gard, 30029
About this study
Official title: 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
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.
Read the detailed description
Cervical cancer is an invasive cancer that develops from the squamous epithelium of the cervix. Worldwide, cervical cancer is the fourth most common cancer in women, with approximately 604,000 new cases in 2020.Treatment for locally advanced cervical cancer (FIGO stage IB3 to IVA) is based on a combination of radiotherapy and chemotherapy (cisplatin 40 mg/m2 x5 or 6 or carboplatin area under the curve 2 if cisplatin is contraindicated). Responses to concomitant chemoradiotherapy remain highly heterogeneous from one woman to another, and predicting the response to these treatments would allow early consideration of alternative therapies for patients identified as less responsive to standard treatments. Indeed, 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.
The radiomic MRI approach in locally advanced cervical cancers has shown in a few studies to be prognostic for locoregional recurrence or survival. However, these models still need to be explored and validated before they can be implemented in routine clinical practice.
The EPICOL cohort is a clinical-biological cohort of 136 patients treated with chemoradiotherapy for locally advanced cervical cancer at the Montpellier Cancer Institute or Nîmes University Hospital.
The aim is to develop a predictive model of response to chemoradiotherapy based on radiomic data from pelvic MRIs before and after treatment from the EPICOL cohort.
- Keywords
- cancer, cervix, survival modeling, radiomic models
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 24
Secondary outcomes (3)
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.
Measured: Month 24
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.
Measured: Month 24
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.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305727
- Sponsor's protocol ID
- SIRIC/2024/FF01
- Acronym
- EPICOL-R
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pang SS, Murphy M, Markham MJ. Current Management of Locally Advanced and Metastatic Cervical Cancer in the United States. JCO Oncol Pract. 2022 Jun;18(6):417-422. doi: 10.1200/OP.21.00795. Epub 2022 Mar 14.
PubMed 35286157Zola P, Fuso L, Mazzola S, Piovano E, Perotto S, Gadducci A, Galletto L, Landoni F, Maggino T, Raspagliesi F, Sartori E, Scambia G. Could follow-up different modalities play a role in asymptomatic cervical cancer relapses diagnosis? An Italian multicenter retrospective analysis. Gynecol Oncol. 2007 Oct;107(1 Suppl 1):S150-4. doi: 10.1016/j.ygyno.2007.07.028. Epub 2007 Sep 14.
PubMed 17868785Autorino R, Gui B, Panza G, Boldrini L, Cusumano D, Russo L, Nardangeli A, Persiani S, Campitelli M, Ferrandina G, Macchia G, Valentini V, Gambacorta MA, Manfredi R. Radiomics-based prediction of two-year clinical outcome in locally advanced cervical cancer patients undergoing neoadjuvant chemoradiotherapy. Radiol Med. 2022 May;127(5):498-506. doi: 10.1007/s11547-022-01482-9. Epub 2022 Mar 24.
PubMed 35325372Bizzarri N, Russo L, Dolciami M, Zormpas-Petridis K, Boldrini L, Querleu D, Ferrandina G, Pedone Anchora L, Gui B, Sala E, Scambia G. Radiomics systematic review in cervical cancer: gynecological oncologists' perspective. Int J Gynecol Cancer. 2023 Oct 2;33(10):1522-1541. doi: 10.1136/ijgc-2023-004589.
PubMed 37714669Halle MK, Hodneland E, Wagner-Larsen KS, Lura NG, Fasmer KE, Berg HF, Stokowy T, Srivastava A, Forsse D, Hoivik EA, Woie K, Bertelsen BI, Krakstad C, Haldorsen IS. Radiomic profiles improve prognostication and reveal targets for therapy in cervical cancer. Sci Rep. 2024 May 17;14(1):11339. doi: 10.1038/s41598-024-61271-4.
PubMed 38760387Li H, Zhu M, Jian L, Bi F, Zhang X, Fang C, Wang Y, Wang J, Wu N, Yu X. Radiomic Score as a Potential Imaging Biomarker for Predicting Survival in Patients With Cervical Cancer. Front Oncol. 2021 Aug 16;11:706043. doi: 10.3389/fonc.2021.706043. eCollection 2021.
PubMed 34485139
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07305727
- Acronym / sponsor ID
- EPICOL-R / SIRIC/2024/FF01
- Keywords
- cancer, cervix, survival modeling, radiomic models
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Dec 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.
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.
Detailed description
Cervical cancer is an invasive cancer that develops from the squamous epithelium of the cervix. Worldwide, cervical cancer is the fourth most common cancer in women, with approximately 604,000 new cases in 2020.Treatment for locally advanced cervical cancer (FIGO stage IB3 to IVA) is based on a combination of radiotherapy and chemotherapy (cisplatin 40 mg/m2 x5 or 6 or carboplatin area under the curve 2 if cisplatin is contraindicated). Responses to concomitant chemoradiotherapy remain highly heterogeneous from one woman to another, and predicting the response to these treatments would allow early consideration of alternative therapies for patients identified as less responsive to standard treatments. Indeed, 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.
The radiomic MRI approach in locally advanced cervical cancers has shown in a few studies to be prognostic for locoregional recurrence or survival. However, these models still need to be explored and validated before they can be implemented in routine clinical practice.
The EPICOL cohort is a clinical-biological cohort of 136 patients treated with chemoradiotherapy for locally advanced cervical cancer at the Montpellier Cancer Institute or Nîmes University Hospital.
The aim is to develop a predictive model of response to chemoradiotherapy based on radiomic data from pelvic MRIs before and after treatment from the EPICOL cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, data from 120 patients for whom we have MRI data from the EPICOL cohort (136 patients included) will be used.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under judicial protection, guardianship, or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic role of a magnetic resonance imaging radiomic model on progression-free survival in patients treated for locally advanced cervical cancer.
Time frame: Month 24
Time from diagnosis to death from any cause or progression (according to RECIST v1.1 criteria) at 24 months of follow-up.
3 secondary outcomes
Prognostic role of an magnetic resonance imaging radiomic model on overall survival in patients treated for locally advanced cervical cancer.
Time frame: Month 24
Correlation between the radiomic magnetic imaging radiomic model and Programmed cell Death protein 1 (PD-L1) expression.
Time frame: Month 24
Correlation between the radiomic magnetic resonance imaging model and tumor-infiltrating lymphocytes (TILs).
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 35286157Pang SS, Murphy M, Markham MJ. Current Management of Locally Advanced and Metastatic Cervical Cancer in the United States. JCO Oncol Pract. 2022 Jun;18(6):417-422. doi: 10.1200/OP.21.00795. Epub 2022 Mar 14.
- Background: PubMed 17868785Zola P, Fuso L, Mazzola S, Piovano E, Perotto S, Gadducci A, Galletto L, Landoni F, Maggino T, Raspagliesi F, Sartori E, Scambia G. Could follow-up different modalities play a role in asymptomatic cervical cancer relapses diagnosis? An Italian multicenter retrospective analysis. Gynecol Oncol. 2007 Oct;107(1 Suppl 1):S150-4. doi: 10.1016/j.ygyno.2007.07.028. Epub 2007 Sep 14.
- Background: PubMed 35325372Autorino R, Gui B, Panza G, Boldrini L, Cusumano D, Russo L, Nardangeli A, Persiani S, Campitelli M, Ferrandina G, Macchia G, Valentini V, Gambacorta MA, Manfredi R. Radiomics-based prediction of two-year clinical outcome in locally advanced cervical cancer patients undergoing neoadjuvant chemoradiotherapy. Radiol Med. 2022 May;127(5):498-506. doi: 10.1007/s11547-022-01482-9. Epub 2022 Mar 24.
- Background: PubMed 37714669Bizzarri N, Russo L, Dolciami M, Zormpas-Petridis K, Boldrini L, Querleu D, Ferrandina G, Pedone Anchora L, Gui B, Sala E, Scambia G. Radiomics systematic review in cervical cancer: gynecological oncologists' perspective. Int J Gynecol Cancer. 2023 Oct 2;33(10):1522-1541. doi: 10.1136/ijgc-2023-004589.
- Background: PubMed 38760387Halle MK, Hodneland E, Wagner-Larsen KS, Lura NG, Fasmer KE, Berg HF, Stokowy T, Srivastava A, Forsse D, Hoivik EA, Woie K, Bertelsen BI, Krakstad C, Haldorsen IS. Radiomic profiles improve prognostication and reveal targets for therapy in cervical cancer. Sci Rep. 2024 May 17;14(1):11339. doi: 10.1038/s41598-024-61271-4.
- Background: PubMed 34485139Li H, Zhu M, Jian L, Bi F, Zhang X, Fang C, Wang Y, Wang J, Wu N, Yu X. Radiomic Score as a Potential Imaging Biomarker for Predicting Survival in Patients With Cervical Cancer. Front Oncol. 2021 Aug 16;11:706043. doi: 10.3389/fonc.2021.706043. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Cervical Cancer by FIGO Stage 2018, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric FITENI, Professor (+334.34.03.46.69, frederic.fiteni@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic role of a magnetic resonance imaging radiomic model on progression-free survival in patients treated for locally advanced cervical cancer. (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07305727, which also lists 6 linked publications.
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 7 Jan 2026.