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Trial 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
NCT ID:
NCT05856565
Condition:
Metastatic Melanoma
Conditions: Official terms:
Melanoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Photo
Description:
Photography intake
Arm group label:
Prospective
Arm group label:
Retrospective
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. 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.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Besancon University Hospital
Address:
City:
Besançon
Zip:
25000
Country:
France
Status:
Recruiting
Contact:
Last name:
Charlée NARDIN, PH
Phone:
33 3.81.21.80.97
Email:
cnardin@chu-besancon.fr
Facility:
Name:
Brest University Hospital
Address:
City:
Brest
Zip:
29000
Country:
France
Status:
Recruiting
Contact:
Last name:
Delphine LEGOUPIL, PH
Phone:
33 2.98.22.37.46
Email:
delphine.legoupil@chu-brest.fr
Facility:
Name:
Angers University Hospital
Address:
City:
Angers
Zip:
49000
Country:
France
Status:
Recruiting
Contact:
Last name:
Yannick LE CORRE, PH
Phone:
33 2.41.35.34.19
Email:
yalecorre@chu-angers.fr
Facility:
Name:
Nantes University Hospital
Address:
City:
Nantes
Country:
France
Status:
Recruiting
Contact:
Last name:
Lise Boussemart, PU-PH
Start date:
July 24, 2023
Completion date:
July 24, 2028
Lead sponsor:
Agency:
Nantes University Hospital
Agency class:
Other
Source:
Nantes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05856565
