Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

Fondazione Policlinico Universitario Agostino Gemelli IRCCS30 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Cancer

Interventions

SurveyOTHER

MRI examinations will be performed on 1.5T or 3T scanners, with protocol according to ESUR guidelines.The contextual structured report will be generated by the investigators in consensus. In every centre, one report (structured or narrative) will be generated from various radiologists experienced in gynaecologic imaging during clinical practice. Two radiologists in consensus, will develop the second version (narrative or structured report).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Advanced Radiology Center

Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

Efficacy of a contextual structured report

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)

Time frame: 1 year

Secondary Outcomes

Satisfaction rate with narrative and structured report

To investigate the satisfaction rate of physicians between narrative and structured report

Time frame: 1 year

Comparison Single items response rate, on both narrative and structured reports

To compare Single items response rate (for items 6 to 12 of the questionnaire related to clinical information), on both narrative and structured reports.

Time frame: 1 year

Differences in the single 6-to-12 items response rate between structured and narrative reports.

To find differences in the single 6-to-12 items response rate between structured and narrative reports.

Time frame: 1 year

Central Contacts

Russo Luca

CONTACT

+390630158637 luca.russo@unicatt.it

Data from ClinicalTrials.gov

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