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NCT Number: NCT06260358

Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

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

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Efficacy of a contextual structured report

    Time frame: 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 outcomes

  1. Satisfaction rate with narrative and structured report

    Time frame: 1 year

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

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

    Time frame: 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.

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

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Russo Luca

CONTACT

[email protected]

+390630158637

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: STRECC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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