Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

Cervical Cancer Clinical Trial

— STRECC  

Official title:

Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260358
• Other study ID #: 6043
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Russo Luca
• Phone: +390630158637
• Email: luca.russo[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Italy	Advanced Radiology Center	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Secondary	Difference between satisfaction rate with narrative and structured report;		1 year
Secondary	Comparison Single items response rate (for items 6 to 12 of the questionnaire related to clinical information), on both narrative and structured reports;		1 year
Secondary	Differences in the single 6-to-12 items response rate between structured and narrative reports.		1 year