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.

NCT06877065 | Recruiting

• 1 other identifier: 6280
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.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

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  3 years

Secondary Outcomes (2)

• The accuracy of MRI in evaluating treatment response after fertility-sparing treatment in cervical cancer, including specificity and sensibility

  3 years

• Assessment of MRI Parameter to predict more aggressive disease

  3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Advanced Radiology Center- Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Benedetta Gui

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedetta Gui

CONTACT

+390630158637; benedetta.gui@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 14, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)