Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

NCT06260358 | Recruiting

• 1 other identifier: 6043
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Satisfaction rate with narrative and structured report

  1 year

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

  1 year

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

  1 year

Interventions

Survey OTHER

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 Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with biopsy-proven cervical cancer (any FIGO stage) undergoing staging MRI afferent to the participating centers satisfying the following inclusion/exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Advanced Radiology Center

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Evis Sala, Prof

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Russo Luca

CONTACT

+390630158637; luca.russo@unicatt.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: March 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

IT (1)