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

March 3, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Active, not recruiting

Conditions

Melanoma Neoplasms

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.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Bologna, Italy, 40138
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of metastatic UM or MM or MUP will be enrolled

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melanoma circulating tumor cell (CTC) count (number of CTC/ml) Time Frame: 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	At enrollment and at every scheduled follow-up visits throughtout the study (24 months)
Circulating microRNAs (copies/ml) Time Frame: 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	At enrollment and at every scheduled follow-up visits throughtout the study (24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: 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	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 Time Frame: 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	Throughtout the study duration (24 months) for a minumum of 6 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Andrea Ardizzoni, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)