An observational study in Metastatic Melanoma, sponsored by Institut Jean-Godinot. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Institut Jean-Godinot · Observational
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.
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.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 100 is below the median of 187 across 488 observational studies indexed under Melanoma.
Browse Melanoma studies →Institut Jean-Godinot is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
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adult with metastatic melanoma treated by immunotherapy
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
adult with metastatic melanoma treated by immunotherapy
Other: data collection
helioderma evaluation
Helioderma
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): * 0: no sign * 1: actinic lentigo, wrinkles, telangiectasia, loss of laxity, thinning * 2: thick, yellowish and/or dry skin, deep wrinkles, irregular pigmentation (hyper-hypopigmented spots) * 3: actinic keratosis, basal cell carcinoma, squamous cell carcinoma
Time frame: Day 0
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Plan to share: No
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This study is not yet recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Institut Jean-Godinot