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Not yet recruitingNCT06780397Mel-Immuno-ReuUpdated Jan 17, 2025

Clinical and Ultrasound Incidence of Rheumatologic Immune Related Adverse Events in Stage IIB-IV Melanoma Patients

An observational study in Melanoma, Stage II, Melanoma Stage III and Melanoma Stage IV, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Melanoma, Stage II
  • Melanoma Stage III
  • Melanoma Stage IV

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03

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's planned enrollment of 100 is below the median of 182 across 448 observational studies indexed under Melanoma.

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Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.

Browse Fondazione Policlinico Universitario Agostino Gemelli IRCCS studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients affected by stage IIB-IV melanoma who start systemic therapy with immune-checkpoint inhibitors.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testJoint ultrasonography

    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.

  • OtherEuropean Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 version 3.0

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

  2. 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.

    Time frame: 3 years

  3. 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.

    Time frame: 3 years

07

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Dermatologia
    Rome, Lazio 00168, Italy
    • Ketty Peris, Prof · Contact · ketty.peris@policlinicogemelli.it · +390630154211
    • Maria Mannino, MD · Contact · mariamannino04@yahoo.it
    • Ketty Peris · Principal investigator
    • Alessandro Di Stefani · Sub investigator
    • Maria Mannino · Sub investigator
    • Laura Quattrini · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Feb 2027, 24 months later.

Of 154 non-industry observational studies under Melanoma, half reached primary completion within 189 months of starting (the median), counting those still running; a quarter within 44. This study's planned 24 months is below that.

Counting every sponsor, half of 206 studies reached it within 82 months; a quarter within 37 and three quarters within 223.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2025
First posted
Jan 17, 2025
StartEst.
Feb 1, 2025
Primary completionEst.
Feb 1, 2027
CompletionEst.
Feb 1, 2028
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06780397
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Jan 17, 2025

Study contacts

Ketty Peris, Prof
Contact
ketty.peris@policlinicogemelli.it
+390630154211
Ketty Peris, Prof
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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