Melanoma, Stage IIMel-Immuno-ReuNCT06780397
Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients
An observational study of Melanoma, Stage II and Melanoma Stage III, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed. The main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Stage II, Melanoma Stage III, Melanoma Stage IV
- What is being tested?
- Joint ultrasonography and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 1 Feb 2028
- 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: Adult patients affected by stage IIB-IV melanoma who start systemic therapy with immune-checkpoint inhibitors.
Who may be able to join
- Adult patients affected by stage IIB, IIC, III and IV melanoma who start systemic therapy with immune-checkpoint inhibitors.
- Signature of the patient consent to the study.
Who cannot join
- Patients aged below 18 years of age.
- Patients who are unable to express consent to the study.
- Patients with a diagnosis of chronic joint diseases: inflammatory arthritis, arthrosis, microcrystalline arthritis, septic arthritis etc.
- Systemic diseases with likely joint involvement (inflammatory bowel disease, etc.)
- Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia
Rome, Lazio, 00168
Ketty Peris, Prof, +390630154211, ketty.peris@policlinicogemelli.it
Maria Mannino, MD, mariamannino04@yahoo.it
About this study
Official title: Monocentric Study on the Clinical and Ultrasound Incidence of Rheumathologic Immune Related Adverse Events in Patients Affected by Stage IIB, IIC, III and IV Melanoma Under Therapy With Immune-checkpoint Inhibitors
Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.
The main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a cohort of patients affected by stage IIB, IIC, III and IV melanoma undergoing treatment with immune-checkpoint inhibitors.
Read more
Patients will:
- receive immune-checkpoint inhibitor therapy, according to disease stage and current National Guidelines.
- undergo dermatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
- undergo rheumatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
- receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
- Conditions
- Melanoma, Stage II, Melanoma Stage III, Melanoma Stage IV
- Being tested
- Joint ultrasonography, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint ultrasonographyDiagnostic test
Patients will undergo rheumatologic visits at baseline and scheduled follow-ups.
Rheumatologic visit procedures:
- collection of patients' anamnesis of rheumatologic diaseases.
- identification of painful and/or swollen joints and enthesis.
- evaluation of joint and enthesis pain.
- joint ultrasonography and assessment of joint structures and enthesis.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0Other
Patients will undergo dermatologic visits at baseline and scheduled follow-ups.
Dermatologic visit procedures:
- collection of patients' oncologic anamnesis and general personal and lifestyle information.
- administration of the quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) to assess the impact of rheumatologic adverse events on patients' quality of life.
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the incidence of rheumatologic immune related adverse events during immune-checkpoint inhibitor treatment in stage IIB-IV melanoma patients.
Patients will undergo a rheumatologic visit and joint ultrasonography at baseline and at scheduled follow-ups in order to assess the incidence of rheumatologic immune related adverse events.
Measured: 3 years
Secondary outcomes (3)
Description of the main characteristics of the rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy.
A rheumatologist will clinically and ultrasonographically characterize the main features of the rheumatologic immune related adverse events occuring during immunotherapy.
Measured: 3 years
Identification of baseline risk factors associated with occurrence of rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy.
Baseline clinical, dermatological, rheumatologic and ultrasonographic factors will be recorded and associated with the occurrence of rheumatologic immune related adverse events during immunotherapy.
Measured: 3 years
Evaluation of rheumatologic adverse events impact on patients' quality of life.
Patients will receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) at baseline and at scheduled timepoints, in order to investigate the impact of the occurrence of rheumatologic adverse events on patients' quality of life.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma, Stage IIStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketty Peris, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780397
- Sponsor's protocol ID
- 6839
- Acronym
- Mel-Immuno-Reu
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Study on the Clinical and Ultrasound Incidence of Rheumathologic Immune Related Adverse Events in Patients Affected by Stage IIB, IIC, III and IV Melanoma Under Therapy With Immune-checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06780397
- Acronym / sponsor ID
- Mel-Immuno-Reu / 6839
- Conditions
- Melanoma, Stage II, Melanoma Stage III, Melanoma Stage IV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 17 Jan 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.
Rheumatologic adverse events are expected to affect between 3% and 7.5% of patients undergoing immunotherapy and are likely to be underdiagnosed.
The main aim of this observational prospective study is to investigate the clinical and ultrasonographic incidence of rheumathologic immune related adverse events in a cohort of patients affected by stage IIB, IIC, III and IV melanoma undergoing treatment with immune-checkpoint inhibitors.
Patients will:
- receive immune-checkpoint inhibitor therapy, according to disease stage and current National Guidelines.
- undergo dermatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
- undergo rheumatologic visit prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
- receive a quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) prior to the start of immune-checkpoint inhibitor therapy and at scheduled follow-ups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients affected by stage IIB-IV melanoma who start systemic therapy with immune-checkpoint inhibitors.
Key inclusion criteria (2 listed)
- Adult patients affected by stage IIB, IIC, III and IV melanoma who start systemic therapy with immune-checkpoint inhibitors.
- Signature of the patient consent to the study.
Key exclusion criteria (5 listed)
- Patients aged below 18 years of age.
- Patients who are unable to express consent to the study.
- Patients with a diagnosis of chronic joint diseases: inflammatory arthritis, arthrosis, microcrystalline arthritis, septic arthritis etc.
- Systemic diseases with likely joint involvement (inflammatory bowel disease, etc.)
- Previous treatments with immune-checkpoint inhibitors or previous adjuvant therapy with immune-checkpoint inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint ultrasonographyPatients will undergo rheumatologic visits at baseline and scheduled follow-ups. Rheumatologic visit procedures: * collection of patients' anamnesis of rheumatologic diaseases. * identification of painful and/or swollen joints and enthesis. * evaluation of joint and enthesis pain. * joint ultrasonography and assessment of joint structures and enthesis. | Diagnostic test | – |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0Patients will undergo dermatologic visits at baseline and scheduled follow-ups. Dermatologic visit procedures: * collection of patients' oncologic anamnesis and general personal and lifestyle information. * administration of the quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0) to assess the impact of rheumatologic adverse events on patients' quality of life. | Other | – |
Primary outcome
Investigation of the incidence of rheumatologic immune related adverse events during immune-checkpoint inhibitor treatment in stage IIB-IV melanoma patients.
Time frame: 3 years
Patients will undergo a rheumatologic visit and joint ultrasonography at baseline and at scheduled follow-ups in order to assess the incidence of rheumatologic immune related adverse events.
3 secondary outcomes
Description of the main characteristics of the rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy.
Time frame: 3 years
Identification of baseline risk factors associated with occurrence of rheumatologic immune related adverse events in stage IIB-IV melanoma patients under immune-checkpoint inhibitor therapy.
Time frame: 3 years
Evaluation of rheumatologic adverse events impact on patients' quality of life.
Time frame: 3 years
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 17 Jan 2025.
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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.
Ketty Peris, Prof principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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, Stage II and Melanoma Stage III, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Jan 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?
Contact Ketty Peris, Prof (+390630154211, ketty.peris@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of the incidence of rheumatologic immune related adverse events during immune-checkpoint inhibitor treatment in stage IIB-IV melanoma patients. (time frame: 3 years). 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 17 Jan 2025.