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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Establishment of a digital ultrasound image biobank including follow-up data | Systematic prospective collection and storage of 2D ultrasound images and video clips from patients undergoing gynecological ultrasound examinations. Each record will be associated with follow-up data, including histological results (within 3 months post-surgery, if applicable) and/or ultrasound re-evaluation (at 1-year follow-up). The goal is to generate a comprehensive image biobank for future research, including artificial intelligence studies. | Up to 12 months after initial ultrasound examination (including follow-up data) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of enrolled patients with complete follow-up data (histological results or 1-year ultrasound) | Proportion of patients for whom follow-up data are available, defined as histological examination results within 3 months for those undergoing surgery, or ultrasound follow-up findings at 1 year for those not undergoing surgery. | Up to 12 months after initial ultrasound examination |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who come to undergo an ultrasound examination at the Class Ultrasound OMIC Center fulfilling the inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonia Carla Testa | Contact | 0630156399 | antoniacarla.testa@policlinicogemelli.it | |
| Francesca Moro | Contact | 0630156399 | francesca.moro@guest.policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonia Carla Testa | Fondazione Policlinico Universitario Agostino Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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