Status:

RECRUITING

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.

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Cervical Cancer

Eligibility:

FEMALE

18+ years

Brief 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....

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, dur...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2028

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06877065

Start Date

March 1 2024

End Date

December 31 2028

Last Update

March 14 2025

Active Locations (1)

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Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168