Generation of an Artificial Intelligence Algorithm Based on the Analysis of Melanoma Peri-scar Dermatoheliosis, as a Predictive Factor of Response to Anti-PD-1
Condition(s) studied
Investigational drug(s) / intervention(s)
Photo: Photography intake
Study summary
In the last decade, the advent of immunotherapies with inhibitors of immune checkpoints, such as anti-PD-1 and anti-CTLA-4, has revolutionized the treatment of advanced or metastatic melanoma. However, the clinical benefit remains limited to a subset of patients. Identifying the patients most likely to benefit from these novel therapies (and avoiding unnecessary toxicity in non-responding patients) is therefore critical. Previous studies found a significant link between the high mutational load of a tumor (TMB) and its response to anti-PD-1 monotherapy, regardless of the histological type of cancer. Unfortunately, TMB measurement is expensive, and requires extensive sequencing approaches difficult to implement in clinical practice. I have shown that melanomas known to be secondary to mutagenic ultraviolet rays (UVR) often carry a high TMB. The cumulative UVR damage translates into visible stigmas termed "dermatoheliosis" on patients' skin, easy to recognize with the naked eye of the clinician around the scar of the primary melanoma. My project proposes to establish, for the first time, dermatoheliosis as a novel predictive factor of response to anti-PD-1 immunotherapy, to be used within multidisciplinary tumor boards as a powerful decision-support tool to select the best treatment option. Specifically, I will 1) develop, validate and test in a prospective manner, an artificial intelligence (AI)-based algorithm, to assess features of pericicatricial dermatoheliosis based on a collection of photographs obtained from patients with unresectable locally advanced or metastatic melanoma 2) demonstrate the link between dermatoheliosis, TMB, immune and treatment response by characterizing pericicatricial skin single cell transcriptomics, as well as tumor DNA, RNA and host immunological profiles of the patients. This directly accessible, non-invasive, surrogate marker for TMB will be a game changer in clinical practice and will subsequently be translated to other skin cancers.
Eligibility
Primary outcome measure(s)
- Predictive performance of tumor progression score — after 6 months
The predictive score for tumor progression at 6 months will be calculated from the photograph of the excision scar of the patient's primary tumor, as well as the clinical characteristics associated with the prognosis: patient age, sex, phototype, anatomical location and Breslow index of the primary tumour, stage of the skin cancer and WHO performance status at the initiation of the treatment, nature of the treatment administered
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Besancon University Hospital | Besançon | Bourgogne-Franche-Comté | Recruiting |
| Brest University Hospital | Brest | Finistère | Recruiting |
| Angers University Hospital | Angers | Maine-et-Loire | Recruiting |
| Blois Hospital site | Blois | France | Not Yet Recruiting |
| Bordeaux University Hospital | Bordeaux | France | Not Yet Recruiting |
| Dijon University Hospital | Dijon | France | Not Yet Recruiting |
| Grenoble University Hospital | Grenoble | France | Not Yet Recruiting |
| CHU de La Rochelle | La Rochelle | France | Not Yet Recruiting |
| CH du Mans | Le Mans | France | Not Yet Recruiting |
| Léon Site Bérard in Lyon | Lyon | France | Not Yet Recruiting |
| Nantes University Hospital | Nantes | France | Recruiting |
| Ambroise Paré Hospital - APHP | Paris | France | Not Yet Recruiting |
| Avicenne Hospital - APHP | Paris | France | Not Yet Recruiting |
| Bichat Hospital - APHP | Paris | France | Not Yet Recruiting |
| Saint-Louis Hospital - APHP | Paris | France | Not Yet Recruiting |
| CHU de Rennes | Rennes | France | Not Yet Recruiting |
| Eugène Marquis site - Rennes | Rennes | France | Not Yet Recruiting |
| Rouen University Hospital | Rouen | France | Not Yet Recruiting |
| ICO | Saint-Herblain | France | Not Yet Recruiting |
| Valence Hospital Site | Valence | France | Not Yet Recruiting |
More Nantes University Hospital trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05856565 on ClinicalTrials.gov ↗ ← All trials in France