Metastatic MelanomaHELIOPREDICTNCT05856565
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
An observational study of Metastatic Melanoma, run by Nantes University Hospital at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Photo
- How many people
- 700 participants
- Where
- 20 sitesFrance
- Study dates
- 24 Jul 2023to 24 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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,
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- Patients with iatrogenic peri-scar vitiligo,
- Patients who have refused to participate in the research,
- Adults protected by law.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Recruiting
Angers University Hospital
Angers, Maine-et-Loire, 49000
Yannick LE CORRE, PH, 33 2.41.35.34.19, yalecorre@chu-angers.fr
Yannick LE CORRE
- Recruiting
Besancon University Hospital
Besançon, Bourgogne-Franche-Comté, 25000
Charlée NARDIN, PH, 33 3.81.21.80.97, cnardin@chu-besancon.fr
Charlée NARDIN
- Not yet recruiting
Blois Hospital site
Blois
Guido BENS, 33 2.54.55.64.95, bensgui@ch-blois.fr
Guido BENS
- Not yet recruiting
Bordeaux University Hospital
Bordeaux
Emilie GERARD, 33 5.56.79.49.62, emilie.gerard@chu-bordeaux.fr
Emilie GERARD
- Recruiting
Brest University Hospital
Brest, Finistère, 29000
Delphine LEGOUPIL, PH, 33 2.98.22.37.46, delphine.legoupil@chu-brest.fr
Delphine LEGOUPIL
- Not yet recruiting
Dijon University Hospital
Dijon
Géraldine JEUDY, 33 3.80.29.33.36, geraldine.jeudy@chu-dijon.fr
Géraldine JEUDY
- Not yet recruiting
Grenoble University Hospital
Grenoble
Julie CHARLES, 33 4.76.76.70.81, JCharles@chu-grenoble.fr
Julie CHARLES
- Not yet recruiting
CHU de La Rochelle
La Rochelle
Cécile FRÉNARD, 33 5.46.45.51.83, Cecile.FRENARD@ght-atlantique17.fr
Cécile FRÉNARD
- Not yet recruiting
CH du Mans
Le Mans
Nathalie BENETON-BENHARD, 33 2.43.43.43.43, nbeneton@ch-lemans.fr
Nathalie BENETON-BENHARD
- Not yet recruiting
Léon Site Bérard in Lyon
Lyon
Mona AMINI-ADLE, 33 4.78.78.59.96, Mona.AMINI-ADLE@lyon.unicancer.fr
Mona AMINI-ADLE
- Recruiting
Nantes University Hospital
Nantes
Lise Boussemart, PU-PH, 33 2.40.08.31.16, lise.boussemart@chu-nantes.fr
Lise BOUSSEMART
- Not yet recruiting
Ambroise Paré Hospital - APHP
Paris
Elisa FUNCK BRENTANO, 33 1.49.09.56.85, elisa.funck-brentano@aphp.fr
Elisa FUNCK BRENTANO
- Not yet recruiting
Avicenne Hospital - APHP
Paris
Eve MAUBEC, 33 1.48.95.77.07, eve.maubec@aphp.fr
Eve MAUBEC
- Not yet recruiting
Bichat Hospital - APHP
Paris
Caroline FAUCON, 33 1.40.25.85.96, caroline.faucon@aphp.fr
Caroline FAUCON
- Not yet recruiting
Saint-Louis Hospital - APHP
Paris
Céleste LEBBE, 33 1.42.49.99.61, celeste.lebbe@aphp.fr
Céleste LEBBE
- Not yet recruiting
CHU de Rennes
Rennes
Monica DINULESCU, 33 2.99.28.43.49, monica.dinulescu@chu-rennes.fr
Monica DINULESCU
- Not yet recruiting
Eugène Marquis site - Rennes
Rennes
Marc PRACHT, 33 2.99.25.31.96, M.pracht@rennes.unicancer.fr
Marc PRACHT
- Not yet recruiting
Rouen University Hospital
Rouen
Anne-Bénédicte DUVAL MODESTE, 33 2.32.88.81.41, ab.duval-modeste@chu-rouen.fr
Anne-Bénédicte DUVAL MODESTE
- Not yet recruiting
ICO
Saint-Herblain
Clément CHARPENTIER, 33 2.40.67.98.93, clement.charpentier@ico.unicancer.fr
Clément CHARPENTIER
- Not yet recruiting
Valence Hospital Site
Valence
Florent GRANGE, 33 4 75 75 75 49, fgrange@ch-valence.fr
Florent GRANGE
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 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.
- Conditions
- Metastatic Melanoma
- Being tested
- Photo
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotoOther
Photography intake
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Photograph Receives: Other: Photo | |
| Prospective | Not described Receives: Other: Photo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance of tumor progression score
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
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start24 Jul 2023
- Primary completion24 Jul 2028 (estimated)
- Study completion24 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856565
- Sponsor's protocol ID
- RC22_0309
- Acronym
- HELIOPREDICT
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05856565
- Acronym / sponsor ID
- HELIOPREDICT / RC22_0309
- Conditions
- Metastatic Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Jul 2028 (estimated)
- Study completion
- 24 Jul 2028 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Other: PhotoPhotograph |
| Prospective | – | Other: Photo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotoPhotography intake | Other | Prospective, Retrospective |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by Nantes University Hospital at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise BOUSSEMART, PU-PH (+33240083116, lise.boussemart@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of tumor progression score (time frame: after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.