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Study identifier: NCT05856565 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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: Metastatic Melanoma  ·  Sponsor: Nantes University Hospital

PhaseN/A
Planned participants700
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Lise BOUSSEMART, PU-PH  ·  +33240083116  ·  lise.boussemart@chu-nantes.fr

Always discuss trial participation with your own doctor first.

Locations (20)

Besancon University HospitalBesançon, Bourgogne-Franche-Comté, FranceRecruiting
Brest University HospitalBrest, Finistère, FranceRecruiting
Angers University HospitalAngers, Maine-et-Loire, FranceRecruiting
Blois Hospital siteBlois, FranceNot Yet Recruiting
Bordeaux University HospitalBordeaux, FranceNot Yet Recruiting
Dijon University HospitalDijon, FranceNot Yet Recruiting
Grenoble University HospitalGrenoble, FranceNot Yet Recruiting
CHU de La RochelleLa Rochelle, FranceNot Yet Recruiting
CH du MansLe Mans, FranceNot Yet Recruiting
Léon Site Bérard in LyonLyon, FranceNot Yet Recruiting
Nantes University HospitalNantes, FranceRecruiting
Ambroise Paré Hospital - APHPParis, FranceNot Yet Recruiting

+ 8 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05856565