- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856565
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)
May 3, 2023 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
Study Type
Observational
Enrollment (Anticipated)
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
- Name: Lise BOUSSEMART, MD
- Phone Number: +33240083116
- Email: lise.boussemart@chu-nantes.fr
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 (cutaneous squamous cell carcinoma or basal cell carcinoma)
- Retrospective cohort: patients who received systemic treatment for their inoperable skin cancer for at least 3 months, with at least 6 months of follow-up, without immunosuppression and whose site of the primary tumor is not altered by a concomitant dermatosis
- Prospective cohort: Patients naïve to immunotherapy for the management of their melanoma at the introduction of systemic treatment. Adjuvant immunotherapy tolerated if it has been stopped for at least 6 months before starting the curative treatment
- Patients who have expressed their agreement to participate in the research and who have signed an image rights authorization
Exclusion Criteria:
- Retrospective cohort: Patients who received their systemic skin cancer treatment for less than 90 days
- Patients who received adjuvant immunotherapy in the 6 months preceding the curative treatment
- Patients whose primary skin cancer site cannot be photographed (example of choroidal melanomas, mucosal melanomas except for melanomas with a vulvar or penile starting point, etc.)
- Patients treated with systemic corticosteroids (dose greater than 10 mg/day) at the introduction of the immunotherapy under consideration
- Immunocompromised patients (associated blood disease, human immunodeficiency virus infection, transplant patient, etc.)
- Patients with iatrogenic peri-scarring vitiligo
- Patients who refused to participate in the research
- Adults protected by law
- Pregnant women
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
|
Photography intake
|
Retrospective
Photograph
|
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
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 (Anticipated)
May 15, 2023
Primary Completion (Anticipated)
June 30, 2028
Study Completion (Anticipated)
June 30, 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)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
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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