Clinical trial NCT06476964: Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics
Official title: Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Cancer
Keywords: Actinic keratosis,
Cutaneous squamous cell carcinoma
mitochondria
metabolism
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-06-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A collection of biological samples (skin) will be created to meet the objectives. Skin biopsies will be taken (excluding on face and fold), in accordance with standard practice.

Detailed description: Skin cancers are the most common type of cancer in human. Among them, cutaneous squamous cell carcinomas (cSCCs) represent the 2nd most frequent, with an incidence that continues to grow (+300% between 1994 and 2006) in line with the ageing of the population and sun exposure habits. cSCCs is a multi-stage carcinogenesis model: the pre-cancerous lesion is actinic keratosis (AK), which can either regress or progressively evolve into cSCC in situ and then infiltrating, and in some patients into a metastatic stage, initially lymph node and then distant, life-threatening. cSCCs are classified as low-risk or high-risk according to clinical and histological criteria associated with the risk of recurrence and metastasis. However, there is currently no tool for predicting this risk for a given cSCC, particularly according to its genetic characteristics. Indeed, the high mutation rate makes it difficult to identify specific genetic profiles. Similarly, there is no tool to predict the potential for a precancerous lesion (AK) to regress or to develop into a cSCC. The aim of this study is to characterize the molecular and metabolic features as well as immunologic landscapes of precancerous AK and cSCCs in order to uncover epithelial and immune cell subpopulations supporting tumor progression.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or over,
* Patients with suspected AK, or cSCC lesions (in situ, infiltrating or metastatic),
* Patients able to sign a consent form,
* Patients affiliated to a French Social Security system.

Exclusion Criteria:

* Patients who have previously received systemic treatment (chemotherapy, immunotherapy),
* Patients with cSCC or AK localized on visible zone of the face or folds
* Patients under guardianship or guardianship,
* Patient not affiliated to a French Social Security system.

Primary outcomes:
measure: Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue
timeFrame: Day 1
measure: Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.
timeFrame: Day 1
Secondary outcomes:
measure: percentage of samples in each category (AK, in situ, ...) that present differentiation features are assessed by immunostaining of loricrin, filaggrin, K10
timeFrame: Day 1
measure: percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index
timeFrame: Day 1
measure: percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test)
timeFrame: Day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - Department of Dermatology
Study officials:
affiliation: University Hospital, Bordeaux
name: Marie BEYLOT-BARRY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bordeaux Institute of Oncology
name: Hamid-Reza REZVANI, PhD
role: STUDY_CHAIR
References: