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| ID | Type | Description | Link |
|---|---|---|---|
| 50/20 | Other Identifier | IRCCS I.N.T. "G. Pascale" |
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This is multicentric, interventional, non farmacological and prospective study.
The new CLG platform, a prototype owned by IRCCS Pascale Institute, is able to reconstruct a PMN for the capture of CTCs able to extravasare and colonize tissues at distance, a fundamental requirement to begin the process of metastasis formation. The purpose of the study is to evaluate in vitro the effectiveness of CLG in the isolation, recovery and subsequent molecular characterization of CTCs from peripheral blood of patients suffering from solid neoplasms (endometrium, kidney, colorectal, glioblastoma and lung).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| device (CLG) | Other | The development of an innovative device (CLG) consisting of an aqueous gel based on hyaluronic acid and commercially available (Belotero) able to be loaded and to release chemokine CXCL12 recreating a kind of "fake niche" able to attract immune cells- and CTCs-CXCR4+. The added value is the ability to attract and trap cells capable of leaking out and potentially with a higher metastatic capacity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLG | Device | The development of an innovative device (CLG) consisting of an aqueous gel based on hyaluronic acid and commercially available (Belotero) able to be loaded and to release chemokine CXCL12 recreating a kind of "fake niche" able to attract immune cells- and CTCs-CXCR4+. The added value is the ability to attract and trap cells capable of leaking out and potentially with a higher metastatic capacity. |
| Measure | Description | Time Frame |
|---|---|---|
| In vitro isolation of CTCs. | In vitro isolation of CTCs with high metastatic capacity from peripheral blood through CLG.Gene expression analysis will be performed using 250ng RNA for nCounter FLEX Analysis System (NanoStringTechnologies). Panels analyzed include the PanCancer Pathways and the PanCancer Progression. The data will be analyzed using the nSolver analysis software version 3.0 | 2 years |
| Real-Time PCR to evaluate the expression of Epithelium-Mesenchymal Markers | Expression analysis of Epithelium-Mesenchymal Markers (EPCAM, SNAIL, VIMENTIN, N-CADERIN, E-CADERIN) will be performed using Real-Time PCR. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation of the number and of biological/molecular characteristics of CTCs with the clinical/pathological characteristics of the patients in analysis and their prognosis. | The correlation of the number and of biological/molecular characteristics of CTCs with the clinical/pathological characteristics of the patients in analysis and their prognosis. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Portella | IRCCS I.N.T. "G. Pascale" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istitute Nazionale Tumori - Fondazione G. Pascale | Naples | Italy | ||||
| Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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The development of an innovative device (CLG) consisting of an aqueous gel based on hyaluronic acid and commercially available (Belotero) able to be loaded and to release chemokine CXCL12 recreating a kind of "fake niche" able to attract immune cells- and CTCs-CXCR4+. The added value is the ability to attract and trap cells capable of leaking out and potentially with a higher metastatic capacity.
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| Naples |
| Italy |