Using AI to predict melanoma treatment response based on skin damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop an artificial intelligence algorithm that analyzes visible skin damage, known as dermatoheliosis, to predict patient responses to anti-PD-1 therapy in metastatic melanoma. By leveraging the correlation between high tumor mutational burden (TMB) and UV-induced skin changes, the study seeks to identify patients who are most likely to benefit from immunotherapy. The research will involve both retrospective and prospective cohorts of patients with inoperable melanoma or skin carcinoma who have undergone systemic treatment. The goal is to enhance treatment personalization and minimize unnecessary toxicity for non-responding patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

▪ Adult patients with inoperable stage III or IV melanoma, or inoperable skin carcinoma (squamous cell carcinoma or basal cell carcinoma).

Retrospective cohort: patients who have received curative treatment with anti-PD1, +/- anti-CTLA-4 or anti-LAG-3 for their skin cancer for at least 90 days, with at least 6 months of follow-up, without immunosuppression and whose primary tumour site is not altered by concomitant dermatosis. Adjuvant immunotherapy is tolerated if it was stopped at least 6 months before the start of curative treatment. Interferon is also tolerated if it was stopped at least 6 months before the start of curative treatment. Radiotherapy is tolerated if it did not take place at the site of the primary melanoma scar. For squamous cell carcinomas, prior radiotherapy on the scar is acceptable (it must simply not have been administered during the period of anti-PD-1 treatment in order to be able to reliably assess the response).

Inoperable primary tumours are eligible. Targeted therapy is accepted before the start of curative treatment with immunotherapy.

Chemotherapy is not accepted prior to the initiation of curative treatment with immunotherapy.

▪ Prospective cohort: Patients who have not received immunotherapy for the management of their skin cancer at the start of curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3.

Adjuvant immunotherapy is tolerated if it has been discontinued for at least 6 months prior to the start of curative treatment. Interferon is also tolerated if it has been discontinued for at least 6 months prior to the start of curative treatment. Radiotherapy is tolerated if it has not been administered at the site of the primary cancer scar.

Targeted therapy is accepted before starting curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3.

Chemotherapy is not accepted before the start of curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3.

▪ Patients who have agreed to participate in the research and have signed an image rights authorisation form.

Exclusion criteria:

* Retrospective cohort: Patients who have received curative treatment with anti-PD-1, +/- anti-CTLA-4 or anti-LAG-3 for skin cancer for less than 90 days
* Patients who received adjuvant immunotherapy within 6 months prior to curative treatment
* Patients who received chemotherapy prior to curative treatment
* Patients whose primary skin cancer site cannot be photographed (e.g. choroidal melanomas, mucosal melanomas, with the exception of vulvar or penile melanomas, etc.).
* Patients treated with systemic corticosteroids (dose greater than 10 mg/day) at the start of the immunotherapy in question,
* Patients who are immunocompromised (associated blood disorder, human immunodeficiency virus infection, transplant patients, etc.) at the start of immunotherapy,
* Patients with iatrogenic peri-scar vitiligo,
* Patients who have refused to participate in the research,
* Adults protected by law.

Where it's running

• Besancon University Hospital
  Besançon, Bourgogne-Franche-Comté, France Recruiting
• Brest University Hospital
  Brest, Finistère, France Recruiting
• Angers University Hospital
  Angers, Maine-et-Loire, France Recruiting
• Nantes University Hospital
  Nantes, France Recruiting
• Blois Hospital site
  Blois, France Not yet recruiting
• Bordeaux University Hospital
  Bordeaux, France Not yet recruiting

Study contacts

• Study coordinator: Lise BOUSSEMART, PU-PH
• Email: lise.boussemart@chu-nantes.fr
• Phone: +33240083116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.