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NCT Number: NCT06863870

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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