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Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRUPPO CIRROSI | 32 soggetti uomini o donne, >18 anni con diagnosi di cirrosi epatica di differente eziologiA |
| |
| GRUPPO HCC | 32 pazienti uomini o donne, con diagnosi di neoplasia primitiva del fegato |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sierological test | Diagnostic Test | sierological test: circulant vescicles |
|
| Measure | Description | Time Frame |
|---|---|---|
| primary endpoint | To evaluate the change in extracellular vesicle concentration between the control group and oncology group. The concentration of vesicles per ml of blood will be measured by frequency shift of the plasmonic resonance peak of gold nanostructures following immuno-capture of vesicles. | 12 months |
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Inclusion
Exclusion
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The target population of this study is divided into two groups: a) control group, 32 cirrhotic patients and b) oncology group, 32 patients diagnosed with hepatocellular carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FABRIZIO PIZZOLANTE, MD PhD | Contact | +390630151 | fabrizio.pizzolante@policlinicogemelli.it | |
| Gabriele Ciasca, Professor | Contact | +390630151 | gabriele.ciasca@unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| FABRIZIO PIZZOLANTE | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FPGemelliIRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
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| ID | Term |
|---|---|
| D001768 | Blister |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |