Cervical CancerFEST-CCNCT06877065
Role of MRI Assessment in Fertility Sparing Treatment for Cervical Cancer at Staging and Follow-up and for Identification of Risk Factors for Aggressive Disease.
An observational study of Cervical Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The purpose of this study is to investigate the role of MRI, including DWI, in the staging and evaluation of response to fertility sparing treatment, including both primary surgery Protocol FeST-CC V.1.0 of November 10, 2023 Pag. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 Dec 2028
- 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: Candidate patients will be enrolled among those with cervical cancer, according to inclusion criteria. They will be informed about the possibility of being enrolled in this study during the outpatient clinics/hospitalization examination and will be given an adequate description of this study (objectives of the study, what the participation involves, possible risks and benefits, what the non- participation may entail, possibility of interruption, etc.). In case of enrolment, an informed consent including acceptance to make available the anonymized personal, clinical-laboratory and diagnostic imaging data will be signed.
Who may be able to join
- Patients with cervical cancer FIGO stage up to IB2-IIA1 (T size < 4 cm) wishing to preserve fertility treated at the Oncological Gynecology Unit of Foundation Policlinico Universitario Agostino Gemelli.
- absence of nodal disease,
- no menopausal status
- wish to preserve fertility
- refusal of radical treatment.
- Patients who had a pre-treatment and post-treatment magnetic resonance imaging.
- Availability of digital MR images and histopathological samples.
Who cannot join
- Patients aged under 18 years.
- Neuroendocrine cervical tumours or other rare histology, such as glassy cells or clear cell carcinoma non-HPV related adenocarcinoma.
- ongoing pregnancy at the time of diagnosis.
- Patients without available MR images on digital media or with low quality images.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Benedetta Gui, +39 0630156054, benedetta.gui@policlinicogemelli.it
About this study
The purpose of this study is to investigate the role of MRI, including DWI, in the staging and evaluation of response to fertility sparing treatment, including both primary surgery Protocol FeST-CC V.1.0 of November 10, 2023 Pag. 5 | 23 (RT or CKC) or after NACT, followed by CKC, in patients with ECC (FIGO 2018 stage IB1- IIA1), desiring to preserve their fertility.
Read the detailed description
Cervical cancer represents the fourth-most common cancer in women and the leading gynaecologic malignancies, accounting approximately 570,000 cases and 311,000 deaths in 2018 worldwide. In Europe, during last years, both mean age of pregnant women and number of nulliparous women have increased (2). Age-specific incidence data indicate that 43% of patients with cervical cancer have less than 45 years. As consequence, numerous young women diagnosed with cervical cancer are still desiring to become pregnant.
In women with early-stage cervical cancer (ECC), fertility-sparing surgery techniques include laparoscopic, abdominal or vaginal radical trachelectomy (RT) and cold knife conization (CKC) with or without pelvic lymph nodes dissection. Currently, RT is proposed as fertility-sparing surgery (FSS), alternative to radical hysterectomy, in patients with ECC staged IA1-IB1, as by the 2018 International Federation of Gynecology and Obstetrics (FIGO) classification. According to a recent metanalysis, RT and CKC present similar oncologic outcomes in terms of recurrence rates but CKC presents better obstetrical outcomes in terms of pregnancy rate (36% for CKC vs. 20% for RT) . NCCN suggested RT as an alternative to radical hysterectomy (RH) in young women desiring to preserve fertility with: disease limited to cervix, tumor size < 2 cm (or < 2.5 cm if exophytic lesion), absence of parametrial extension, an estimated distance of ≥ 1 cm from the proximal aspect of the tumor to the internal os, absence of lymphadenopathies or metastatic disease. Some authors have proposed neoadjuvant chemotherapy (NACT) followed by CKC as a safe and effective approach in ECC FIGO stage IB2.
In 2018 FIGO staging was revised allowing the use of any of the imaging modalities (i.e.
ultrasound, CT, MRI, positron emission tomography (PET)), to provide information on tumor size, nodal status, and local or systemic spread. MRI is reported to be very accurate in selecting patients eligible for FSS, in tumor size evaluation and deep stromal invasion assessment. In the evaluation of parametrial invasion, the specificity and negative predictive value of MRI were 97% and 100%, respectively.
Furthermore, MRI has demonstrated very high sensitivity and specificity in assessment of internal os involvement, 90% and 98% respectively. Moreover, MRI including diffusion-weighted imaging (DWI) assumes an important role in the evaluation of tumor response after chemotherapy. In addition, MRI is highly sensitive and accurate (90.7% and 91.7% respectively) in tumor size evaluation after FSS, especially in patients who have undergone cone biopsy before MRI examination.
The purpose of this study is to investigate the role of MRI, including DWI, in the staging and evaluation of response to fertility sparing treatment, including both primary surgery (RT or CKC) or after NACT, followed by CKC, in patients with ECC (FIGO 2018 stage IB1- IIA1), desiring to preserve their fertility.
- Conditions
- Cervical Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | In the retrospective phase of the research, all patients with histological diagnosis of cervical cancer, stage FIGO up to IB2-IIA1 (T size < 4 cm), treated with fertility sparing techniques, from 2018 to 2023, will be identified retrospectively, searching on RedCap database. Of these patients, only those with good quality of MR images (available on digital support) will be selected. | |
| Prospective cohort | In the prospective phase of the research, all patients with histological diagnosis of cervical cancer, FIGO stage up to IB2-IIA1 (T size < 4 cm), that wish to preserve fertility and are suitable for fertility sparing treatments. Of these patients, only those with good quality of MR images (available on digital support) will be selected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI accuracy in preoperative staging of early stage cervical cancer for fertility-sparing treatment
The primary objective is to investigate the role of MRI in preoperative staging of early stage cervical cancer, in patients eligible for fertility-sparing treatment (FIGO stage up to IB2-IIA1 with T size < 4 cm).
Measured: 3 years
Secondary outcomes (2)
The accuracy of MRI in evaluating treatment response after fertility-sparing treatment in cervical cancer, including specificity and sensibility
To assess the accuracy of MRI in evaluating treatment response after fertility-sparing treatment in cervical cancer.
Measured: 3 years
Assessment of MRI Parameter to predict more aggressive disease
To assess if MRI parameters correctly predict more aggressive disease at the time of diagnosis before fertility-sparing treatment, in correlation with the Annual Recurrence Risk Model (ARRM) both in terms of disease-free survival (DFS) and overall survival (OS).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benedetta Gui, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877065
- Sponsor's protocol ID
- 6280
- Acronym
- FEST-CC
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MRI Assessment in Fertility Sparing Treatment for Cervical Cancer at Staging and Follow-up and for Identification of Risk Factors for Aggressive Disease.
- ClinicalTrials.gov ID
- NCT06877065
- Acronym / sponsor ID
- FEST-CC / 6280
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Mar 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.
The purpose of this study is to investigate the role of MRI, including DWI, in the staging and evaluation of response to fertility sparing treatment, including both primary surgery Protocol FeST-CC V.1.0 of November 10, 2023 Pag. 5 | 23 (RT or CKC) or after NACT, followed by CKC, in patients with ECC (FIGO 2018 stage IB1- IIA1), desiring to preserve their fertility.
Detailed description
Cervical cancer represents the fourth-most common cancer in women and the leading gynaecologic malignancies, accounting approximately 570,000 cases and 311,000 deaths in 2018 worldwide. In Europe, during last years, both mean age of pregnant women and number of nulliparous women have increased (2). Age-specific incidence data indicate that 43% of patients with cervical cancer have less than 45 years. As consequence, numerous young women diagnosed with cervical cancer are still desiring to become pregnant.
In women with early-stage cervical cancer (ECC), fertility-sparing surgery techniques include laparoscopic, abdominal or vaginal radical trachelectomy (RT) and cold knife conization (CKC) with or without pelvic lymph nodes dissection. Currently, RT is proposed as fertility-sparing surgery (FSS), alternative to radical hysterectomy, in patients with ECC staged IA1-IB1, as by the 2018 International Federation of Gynecology and Obstetrics (FIGO) classification. According to a recent metanalysis, RT and CKC present similar oncologic outcomes in terms of recurrence rates but CKC presents better obstetrical outcomes in terms of pregnancy rate (36% for CKC vs. 20% for RT) . NCCN suggested RT as an alternative to radical hysterectomy (RH) in young women desiring to preserve fertility with: disease limited to cervix, tumor size < 2 cm (or < 2.5 cm if exophytic lesion), absence of parametrial extension, an estimated distance of ≥ 1 cm from the proximal aspect of the tumor to the internal os, absence of lymphadenopathies or metastatic disease. Some authors have proposed neoadjuvant chemotherapy (NACT) followed by CKC as a safe and effective approach in ECC FIGO stage IB2.
In 2018 FIGO staging was revised allowing the use of any of the imaging modalities (i.e.
ultrasound, CT, MRI, positron emission tomography (PET)), to provide information on tumor size, nodal status, and local or systemic spread. MRI is reported to be very accurate in selecting patients eligible for FSS, in tumor size evaluation and deep stromal invasion assessment. In the evaluation of parametrial invasion, the specificity and negative predictive value of MRI were 97% and 100%, respectively.
Furthermore, MRI has demonstrated very high sensitivity and specificity in assessment of internal os involvement, 90% and 98% respectively. Moreover, MRI including diffusion-weighted imaging (DWI) assumes an important role in the evaluation of tumor response after chemotherapy. In addition, MRI is highly sensitive and accurate (90.7% and 91.7% respectively) in tumor size evaluation after FSS, especially in patients who have undergone cone biopsy before MRI examination.
The purpose of this study is to investigate the role of MRI, including DWI, in the staging and evaluation of response to fertility sparing treatment, including both primary surgery (RT or CKC) or after NACT, followed by CKC, in patients with ECC (FIGO 2018 stage IB1- IIA1), desiring to preserve their fertility.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –In the retrospective phase of the research, all patients with histological diagnosis of cervical cancer, stage FIGO up to IB2-IIA1 (T size < 4 cm), treated with fertility sparing techniques, from 2018 to 2023, will be identified retrospectively, searching on RedCap database. Of these patients, only those with good quality of MR images (available on digital support) will be selected. |
| Prospective cohort | – | –In the prospective phase of the research, all patients with histological diagnosis of cervical cancer, FIGO stage up to IB2-IIA1 (T size < 4 cm), that wish to preserve fertility and are suitable for fertility sparing treatments. Of these patients, only those with good quality of MR images (available on digital support) will be selected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidate patients will be enrolled among those with cervical cancer, according to inclusion criteria. They will be informed about the possibility of being enrolled in this study during the outpatient clinics/hospitalization examination and will be given an adequate description of this study (objectives of the study, what the participation involves, possible risks and benefits, what the non- participation may entail, possibility of interruption, etc.). In case of enrolment, an informed consent including acceptance to make available the anonymized personal, clinical-laboratory and diagnostic imaging data will be signed.
Key inclusion criteria (7 listed)
- Patients with cervical cancer FIGO stage up to IB2-IIA1 (T size < 4 cm) wishing to preserve fertility treated at the Oncological Gynecology Unit of Foundation Policlinico Universitario Agostino Gemelli.
- absence of nodal disease,
- no menopausal status
- wish to preserve fertility
- refusal of radical treatment.
Key exclusion criteria (4 listed)
- Patients aged under 18 years.
- Neuroendocrine cervical tumours or other rare histology, such as glassy cells or clear cell carcinoma non-HPV related adenocarcinoma.
- ongoing pregnancy at the time of diagnosis.
- Patients without available MR images on digital media or with low quality images.
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
MRI accuracy in preoperative staging of early stage cervical cancer for fertility-sparing treatment
Time frame: 3 years
The primary objective is to investigate the role of MRI in preoperative staging of early stage cervical cancer, in patients eligible for fertility-sparing treatment (FIGO stage up to IB2-IIA1 with T size < 4 cm).
2 secondary outcomes
The accuracy of MRI in evaluating treatment response after fertility-sparing treatment in cervical cancer, including specificity and sensibility
Time frame: 3 years
Assessment of MRI Parameter to predict more aggressive disease
Time frame: 3 years
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 14 Mar 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.
Benedetta Gui principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 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 7 inclusion and 4 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 14 Mar 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?
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 Benedetta Gui (+390630158637, benedetta.gui@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI accuracy in preoperative staging of early stage cervical cancer for fertility-sparing treatment (time frame: 3 years). 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 14 Mar 2025.