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AI reads skin scars to pick best cancer treatment

NCT ID NCT05856565

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to develop an artificial intelligence (AI) algorithm that analyzes skin damage (dermatoheliosis) around a melanoma scar to predict whether a patient will respond to anti-PD-1 immunotherapy. Researchers will collect photos and medical data from 700 adults with advanced skin cancer. The goal is to create a simple, non-invasive tool to help doctors choose the most effective treatment for each patient.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ambroise Paré Hospital - APHP

    NOT_YET_RECRUITING

    Paris, France

  • Angers University Hospital

    RECRUITING

    Angers, Maine-et-Loire, 49000, France

  • Avicenne Hospital - APHP

    NOT_YET_RECRUITING

    Paris, France

  • Besancon University Hospital

    RECRUITING

    Besançon, Bourgogne-Franche-Comté, 25000, France

  • Bichat Hospital - APHP

    NOT_YET_RECRUITING

    Paris, France

  • Blois Hospital site

    NOT_YET_RECRUITING

    Blois, France

  • Bordeaux University Hospital

    NOT_YET_RECRUITING

    Bordeaux, France

  • Brest University Hospital

    RECRUITING

    Brest, Finistère, 29000, France

  • CH du Mans

    NOT_YET_RECRUITING

    Le Mans, France

  • CHU de La Rochelle

    NOT_YET_RECRUITING

    La Rochelle, France

  • CHU de Rennes

    NOT_YET_RECRUITING

    Rennes, France

  • Dijon University Hospital

    NOT_YET_RECRUITING

    Dijon, France

  • Eugène Marquis site - Rennes

    NOT_YET_RECRUITING

    Rennes, France

  • Grenoble University Hospital

    NOT_YET_RECRUITING

    Grenoble, France

  • ICO

    NOT_YET_RECRUITING

    Saint-Herblain, France

  • Léon Site Bérard in Lyon

    NOT_YET_RECRUITING

    Lyon, France

  • Nantes University Hospital

    RECRUITING

    Nantes, France

  • Rouen University Hospital

    NOT_YET_RECRUITING

    Rouen, France

  • Saint-Louis Hospital - APHP

    NOT_YET_RECRUITING

    Paris, France

  • Valence Hospital Site

    NOT_YET_RECRUITING

    Valence, France

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