Clinical trial · Observational
Association Between Helioderma and Response to Immunotherapy in Patients With Metastatic Melanoma
NCT05641012CI-TRIAL-00062537HeliomaunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- metastatic melanoma group
- description
- adult with metastatic melanoma treated by immunotherapy
- interventionNames
- Other: data collection
Primary outcomes (1)
- measure
- Helioderma
- timeFrame
- Day 0
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.