Assessment of Circulating Tumor Cells and microRNAs in Patients With Metastatic Non-cutaneous Melanoma

N/AActive Not RecruitingNCT06863870

IRCCS Azienda Ospedaliero-Universitaria di Bologna35 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma Neoplasms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Outcomes

Primary Outcomes

Melanoma circulating tumor cell (CTC) count (number of CTC/ml)

Evaluate CTCs count (number/ml) in patients with metastatic UM, MM and MUP

Time frame: 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

Time frame: At enrollment and at every scheduled follow-up visits throughtout the study (24 months)

Secondary Outcomes

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

Time frame: 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

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

Time frame: Throughtout the study duration (24 months) for a minumum of 6 months for each patient

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.