Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06260358
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.

Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Age ≥18 years old;
• Overt biopsy-proven diagnosis of cervical cancer, at any stage;
• Signed written informed consent to personal data treatment for research purposes

Exclusion Criteria

• Age <18 years old;
• Uncertain diagnosis of cervical cancer;
• MRI scan not according the standard acquisition protocol (ESUR guidelines);
• Patients candidate to non-standard treatments;
• Refusal to sign the written informed consent to personal data treatment for research purposes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of a contextual structured report	1 year	Primary endpoint of the study is to assess referring physicians' (gynecologists and radiation oncologists) overall satisfaction rate with structured reports for staging MRI of patients with cervical cancer, in terms of overall response rate ≥4 at the first 5 items (i.e., an overall score ≥20)

Secondary Outcome Measures

Name	Time	Method
Satisfaction rate with narrative and structured report	1 year	To investigate the satisfaction rate of physicians between narrative and structured report
Comparison Single items response rate, on both narrative and structured reports	1 year	To compare Single items response rate (for items 6 to 12 of the questionnaire related to clinical information), on both narrative and structured reports.
Differences in the single 6-to-12 items response rate between structured and narrative reports.	1 year	To find differences in the single 6-to-12 items response rate between structured and narrative reports.

Trial Locations

Locations (1)

Advanced Radiology Center; 🇮🇹 Rome, Italy