Ultrasound Image Bank: Advancing Medical Research and Diagnostics

NCT ID: NCT07031921

Last Updated: 2025-06-22

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

NOT_YET_RECRUITING

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-25

Study Completion Date

2030-05-30

Brief Summary

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The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. These images will be collected during routine clinical care from both healthy patients and those with benign or malignant gynecological conditions. The goal is to support medical training, clinical research, and the development of artificial intelligence (AI) models for diagnostic purposes.

This is a prospective, observational, single-center study, with an expected enrollment of approximately 25,000 patients over five years. The ultrasound images will be linked to histological outcomes (for those undergoing surgery within 3 months) or to follow-up scans at 1 year, to enhance early diagnosis and personalized treatment approaches.

Detailed Description

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Conditions

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Gynecological Imaging Ultrasound Diagnostics Gynecologic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All patients examined at Class Ultrasound OMIC of Fondazione Policlinico Gemelli, IRCCS in Rome.
* All patients can be enrolled regardless the results of ultrasound examination: no evidence of disease, suspicion of benign or malignant pathologies
* Aged ≥ 18 years old
* Patients who were previously enrolled and their outcome has been completed
* Signature of informed consent

Exclusion Criteria

* No signed informed consent;
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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Antonia Carla Testa

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status

Countries

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Italy

Central Contacts

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Antonia Carla Testa

Role: CONTACT

0630156399

Francesca Moro

Role: CONTACT

0630156399

Facility Contacts

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ANTONIA CARLA TESTA, Professor

Role: primary

0630156399

Other Identifiers

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7692

Identifier Type: -

Identifier Source: org_study_id

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