Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

NCT ID: NCT06260358

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evis Sala, Prof

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Advanced Radiology Center

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Russo Luca

Role: CONTACT

+390630158637

Facility Contacts

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Luca Russo

Role: primary

+390630158637

Other Identifiers

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6043

Identifier Type: -

Identifier Source: org_study_id

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