Melanoma NeoplasmsNCT06863870
Assessment of Circulating Tumor Cells and microRNAs in Patients With Metastatic Non-cutaneous Melanoma
An observational study of Melanoma Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Neoplasms
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 24 May 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of metastatic UM or MM or MUP will be enrolled
Who may be able to join
- Diagnosis of UM, MM or MUP
- Diagnosis of metastatic disease
- Age ≥ 18 years, at the time of the tissue collection
Who cannot join
- Personal medical history of concomitant other cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Melanoma Neoplasms
- Keywords
- uveal melanoma, mucosal melanoma, melanoma primary unknown
- Medical subject headings
- Uveal Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanoma circulating tumor cell (CTC) count (number of CTC/ml)
Evaluate CTCs count (number/ml) in patients with metastatic UM, MM and MUP
Measured: 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
Measured: At enrollment and at every scheduled follow-up visits throughtout the study (24 months)
Secondary outcomes (2)
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
Measured: 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
Measured: Throughtout the study duration (24 months) for a minumum of 6 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start24 May 2023
- Primary completion30 Sep 2024
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma NeoplasmsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Ardizzoni, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863870
- Sponsor's protocol ID
- circMEL 2.0
- Other IDs
- RC-2022-2773352
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Circulating Tumor Cells and microRNAs in Patients With Metastatic Non-cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT06863870
- Acronym / sponsor ID
- circMEL 2.0
- Conditions
- Melanoma Neoplasms
- Keywords
- uveal melanoma, mucosal melanoma, melanoma primary unknown
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of metastatic UM or MM or MUP will be enrolled
Key inclusion criteria (3 listed)
- Diagnosis of UM, MM or MUP
- Diagnosis of metastatic disease
- Age ≥ 18 years, at the time of the tissue collection
Key exclusion criteria (1 listed)
- Personal medical history of concomitant other cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
2 secondary outcomes
Overall Survival (OS)
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
Time frame: Throughtout the study duration (24 months) for a minumum of 6 months for each patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Melanoma Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Ardizzoni, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.