Association Between Helioderma and Response to Immunotherapy in Patients With Metastatic Melanoma (Helioma)
Melanoma is one of the most aggressive forms of skin cancer, representing only 5% of all skin cancer but 80% of all death by skin cancer. Diagnosis and treatment of melanoma must be early because prognosis depends on stage disease.
Immunotherapy is used in metastatic melanoma. However, all patients not respond to immunotherapy.
Helioderma (photoaging) is a marker of exposure to UV rays and therefore of mutagenesis. Thus, helioderma could be associated with the response to immunotherapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The detection and management of melanomas must be very early because the prognosis largely depends on the extent of the disease at the time of diagnosis.
For patients with melanoma, immunotherapy or dual therapy is used as treatment in unresectable and metastatic (AJCC stage IV) cases, depending on mutation status. Primary immunotherapy is possible in mutated patients in the absence of threatening progression.
However, not all patients respond well to immunotherapy, so biomarkers that predict treatment response are needed to optimize patient benefit.
The onset, development, and course of melanoma are based on the accumulation of genomic changes, including high loads of ultraviolet-induced mutations, which make melanoma the most immunogenic tumor. In several tumor types, tumor mutation load (TMB) and immune infiltration have been reported to predict response to immunotherapy. Indeed, the higher the TMB, the more the tumor is likely to produce a neo-tumor antigen, target of the reactivation of the immune system.
No threshold value of TMB has been determined to date, having a predictive value in melanoma. The degree of helioderma could be a potentially discriminating marker of the degree of UV exposure and therefore of mutagenesis. Preliminary results have reported the interest of this approach but must be confirmed because it was a small study (Russo et al).
UV-induced DNA damage results in clinical signs of heliodermia or photoaging: more or less deep wrinkles, loss of elasticity, thinning of the skin, lentigo pigmentary disorders, yellowish color of the skin, telangiectasias, on the skin areas exhibited. Helioderma could therefore be an easily accessible clinical predictor of a good response to immunotherapy.
The aim of the study is to study association between helioderma and response to immunotherapy in patients with metastatic melanoma.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- metastatic melanoma
- Whatever the mutation BRAF status
- treated by immunotherapy or specific therapy
- aged more than 18
- agreeing to participate to the study
Exclusion Criteria:
- Patient whose treatment by immunotherapy has already started
- Patient who have had a radiotherapy or chemotherapy treatment
- Patient with an unknown primary melanoma, choroidal melanoma
- Patient with other cancer (except basal cell and squamous cell skin cancer)
- Patient with genetic predisposition for melanoma
- aged less than 18
- Adult not agreeing to participate to the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
metastatic melanoma group
adult with metastatic melanoma treated by immunotherapy
|
helioderma evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Helioderma
Time Frame: Day 0
|
Helioderma (photoageing) evaluated around the resection scar or melanoma (if no resection) by descriptive scale ranging from 0 to 3 (3 corresponding to strong helioderma):
|
Day 0
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022_HELIOMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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