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| ID | Type | Description | Link |
|---|---|---|---|
| RC-2022-2773352 | Other Grant/Funding Number | Italian Health Ministry |
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the study aims to implement new approaches for the identification of circulating tumor cells and circulating microRNAs, which aim to silence the expression of genes and thus prevent the production of proteins in patients with advanced melanoma (uval, mucosal, of unknown origin). It also aims to verify whether their expression can be related to the prognosis of the disease and the response to treatments.
Here we propose a study to identify a technique for the isolation of circulating tumor cells (CTCs) from blood samples of patients with diagnosis of metastatic melanoma (uveal, mucosal, from primary unknown) to identify a potential role of CTCs and to study the role for circulating microRNAs (miRNAs) in the management of metastatic UM, MM and MUP.
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| Measure | Description | Time Frame |
|---|---|---|
| Melanoma circulating tumor cell (CTC) count (number of CTC/ml) | Evaluate CTCs count (number/ml) in patients with metastatic UM, MM and MUP | At enrollment and at every scheduled follow-up visits throughtout the study (24 months) |
| Circulating microRNAs (copies/ml) | Evaluate circulating microRNAs expression (copies/ul) in patients with metastatic UM, MM and MUP | At enrollment and at every scheduled follow-up visits throughtout the study (24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Evaluate OS throughtout the study period in order to correlate levels of CTC and microRNA with OS of patients with metastatic UM, MM and MUP | Throughtout the study duration (24 months) for a minumum of 6 months for each patient |
| To correlate the count of CTC and the expression of circulating microRNAs with patients' prognosis in order to discover liquid biomarkers for prognosis of UM, MM and MUP |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosis of metastatic UM or MM or MUP will be enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Ardizzoni, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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plasma
Evaluate PFS throughtout the study period in order to correlate levels of CTC and microRNA with PFS of patients with metastatic UM, MM and MUP |
| Throughtout the study duration (24 months) for a minumum of 6 months for each patient |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |