Ultrasound Image Bank: Advancing Medical Research and Diagnostics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gynecological Imaging, Ultrasound Diagnostics, Gynecologic Disease. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Establishment of a digital ultrasound image biobank including follow-up data [Time frame: Up to 12 months after initial ultrasound examination (including follow-up data)]
Secondary outcome measures (1)
- Percentage of enrolled patients with complete follow-up data (histological results or 1-year ultrasound) [Time frame: Up to 12 months after initial ultrasound examination]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Identifiers
NCT: NCT07031921 · 7692