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Recruiting NCT06260358

Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

Observational Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Survey.
Who it may be relevant to
Registry conditions: Cervical Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Interventions

  • Other Survey
    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).

Primary outcome measures

  • Efficacy of a contextual structured report [Time frame: 1 year]
Secondary outcome measures (3)
  • Satisfaction rate with narrative and structured report [Time frame: 1 year]
  • Comparison Single items response rate, 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. [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Advanced Radiology Center — Rome

Identifiers

NCT: NCT06260358 · 6043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗