Cervical Cancer
Conditions
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
Interventions
OTHERSurvey
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).
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactRusso Luca
Outcome results
None listed