Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics
- Conditions
- Skin Cancer
- Interventions
- Procedure: skin biopsies
- Registration Number
- NCT06476964
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patients with squamous cell carcinoma in situ (in situ cSCC) skin biopsies - patients with actinic keratosis(AK) skin biopsies - patients with squamous cell carcinomas infiltrative (infiltrative cSCC) skin biopsies - patient with invasive metastases (cSCC with cutaneous metastases) skin biopsies -
- Primary Outcome Measures
Name Time Method Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated. Day 1 Characterization of the immune cells infiltrate Expression of multiple immune cell markers will be assessed in samples from different subtypes of cSCC by single cell RNA sequencing.
Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue Day 1 Evaluation of metabolic changes involved in cSCC progression
- Secondary Outcome Measures
Name Time Method percentage of samples in each category (AK, in situ, ...) that present differentiation features are assessed by immunostaining of loricrin, filaggrin, K10 Day 1 Evaluation of skin differentiation markers
percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index Day 1 Evaluation of cSCC aggressiveness markers with the percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index, degree of differentiation, invasion beyond subcutaneous fat, perineural invasion, vascular invasion level of infiltration following immunohistochemistry analyses on formalin-fixed paraffin-embedded tissue sections.
percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test) Day 1 Evaluation of cancer proliferative features on skin biopsies with percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test) and cell cycle progression (flow cytometer, western).
Trial Locations
- Locations (1)
University Hospital of Bordeaux - Department of Dermatology
🇫🇷Bordeaux, France