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 (HELIOPREDICT)

April 14, 2026 updated by: Nantes University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Blois, France
        • Not yet recruiting
        • Blois Hospital site
        • Contact:
        • Principal Investigator:
          • Guido Bens
      • Bordeaux, France
        • Not yet recruiting
        • Bordeaux University Hospital
        • Contact:
        • Principal Investigator:
          • Emilie GERARD
      • Dijon, France
        • Not yet recruiting
        • Dijon University Hospital
        • Contact:
        • Principal Investigator:
          • Géraldine Jeudy
      • Grenoble, France
        • Not yet recruiting
        • Grenoble University Hospital
        • Principal Investigator:
          • Julie Charles
        • Contact:
      • La Rochelle, France
        • Not yet recruiting
        • CHU de La Rochelle
        • Contact:
        • Principal Investigator:
          • Cécile FRÉNARD
      • Le Mans, France
        • Not yet recruiting
        • CH du Mans
        • Principal Investigator:
          • Nathalie Beneton-Benhard
        • Contact:
      • Lyon, France
        • Not yet recruiting
        • Léon Site Bérard in Lyon
        • Contact:
        • Principal Investigator:
          • Mona AMINI-ADLE
      • Nantes, France
        • Recruiting
        • Nantes University Hospital
        • Contact:
        • Principal Investigator:
          • Lise BOUSSEMART
      • Paris, France
        • Not yet recruiting
        • Ambroise Paré Hospital - APHP
        • Contact:
        • Principal Investigator:
          • Elisa FUNCK BRENTANO
      • Paris, France
        • Not yet recruiting
        • Avicenne Hospital - APHP
        • Contact:
        • Principal Investigator:
          • Eve Maubec
      • Paris, France
        • Not yet recruiting
        • Bichat Hospital - APHP
        • Contact:
        • Principal Investigator:
          • Caroline FAUCON
      • Paris, France
        • Not yet recruiting
        • Saint-Louis Hospital - APHP
        • Principal Investigator:
          • Céleste Lebbe
        • Contact:
      • Rennes, France
        • Not yet recruiting
        • CHU de Rennes
        • Contact:
        • Principal Investigator:
          • Monica DINULESCU
      • Rennes, France
        • Not yet recruiting
        • Eugène Marquis site - Rennes
        • Principal Investigator:
          • Marc PRACHT
        • Contact:
      • Rouen, France
        • Not yet recruiting
        • Rouen University Hospital
        • Principal Investigator:
          • Anne-Bénédicte DUVAL MODESTE
        • Contact:
      • Saint-Herblain, France
      • Valence, France
        • Not yet recruiting
        • Valence Hospital Site
        • Contact:
        • Principal Investigator:
          • Florent GRANGE
    • Bourgogne-Franche-Comté
      • Besançon, Bourgogne-Franche-Comté, France, 25000
        • Recruiting
        • Besançon University Hospital
        • Contact:
        • Principal Investigator:
          • Charlée NARDIN
    • Finistère
      • Brest, Finistère, France, 29000
        • Recruiting
        • Brest University Hospital
        • Contact:
        • Principal Investigator:
          • Delphine LEGOUPIL
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49000
        • Recruiting
        • Angers University Hospital
        • Contact:
        • Principal Investigator:
          • Yannick LE CORRE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

700 adult patients' cohorts (500 Retrospective and 200 Prospective cohorts), with an unresectable locally advanced or metastatic melanoma skin cancer, insured under a health insurance scheme and for which we will analyze the dermatoheliosis images and the profile data of response to 1st, 2nd and 3rd line of systemic treatment (best observed response, progression-free survival and overall survial).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective
Other: Photo
Photography intake
Retrospective
Photograph
Other: Photo
Photography intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive performance of tumor progression score
Time Frame: 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
after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

July 24, 2028

Study Completion (Estimated)

July 24, 2028

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0309

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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