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Active, not recruitingNCT06863870Updated Mar 7, 2025

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

An observational study in Melanoma Neoplasms, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
35
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Melanoma Neoplasms

Keywords

  • uveal melanoma
  • mucosal melanoma
  • melanoma primary unknown
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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 35 is below the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Personal medical history of concomitant other cancer
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
35 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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)

  2. 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

  1. 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

  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

    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

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Study locations

1 site
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, 40138, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06863870
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Mar 7, 2025
Start date
May 24, 2023
Primary completion
Sep 30, 2024
Completion
Mar 31, 2025 (estimated)
Last update
Mar 7, 2025

Study contacts

Andrea Ardizzoni, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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