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

NCT06863870 | Active Not Recruiting

• 2 other identifiers: circMEL 2.0RC-2022-2773352
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma Neoplasms

Keywords

uveal melanoma; mucosal melanoma; melanoma primary unknown

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Overall Survival (OS)

  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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of UM, MM or MUP
• Diagnosis of metastatic disease
• Age ≥ 18 years, at the time of the tissue collection

You may not qualify if:

• Personal medical history of concomitant other cancer

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Andrea Ardizzoni, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: March 7, 2025
• Study Start: May 24, 2023
• Primary Completion: September 30, 2024
• Study Completion: March 31, 2025
• Last Updated: March 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)