Clinical trial · Observational
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.
NCT06877065CI-TRIAL-00087215FEST-CCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- 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.
- label
- Prospective cohort
- description
- 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.
Primary outcomes (1)
- measure
- MRI accuracy in preoperative staging of early stage cervical cancer for fertility-sparing treatment
- timeFrame
- 3 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.