Melanoma Neoplasms
Conditions
Keywords
uveal melanoma, mucosal melanoma, melanoma primary unknown
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of UM, MM or MUP * Diagnosis of metastatic disease * Age ≥ 18 years, at the time of the tissue collection
Exclusion criteria
* Personal medical history of concomitant other cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melanoma circulating tumor cell (CTC) count (number of CTC/ml) | At enrollment and at every scheduled follow-up visits throughtout the study (24 months) | Evaluate CTCs count (number/ml) in patients with metastatic UM, MM and MUP |
| Circulating microRNAs (copies/ml) | At enrollment and at every scheduled follow-up visits throughtout the study (24 months) | Evaluate circulating microRNAs expression (copies/ul) in patients with metastatic UM, MM and MUP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Throughtout the study duration (24 months) for a minumum of 6 months for each patient | 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 |
| 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 | Throughtout the study duration (24 months) for a minumum of 6 months for each patient | 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 |
Countries
Italy
Outcome results
None listed