Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics (StratiKA)

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer
• Intervention / Treatment: Procedure: skin biopsies

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie BEYLOT-BARRY, MD, PhD; Phone Number: +335 57 82 25 00; Email: marie.beylot-barry@chu-bordeaux.fr
• Study Contact Backup: Name: Christine ALFARO; Phone Number: +335 57 82 25 09; Email: christine.alfaro@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • University Hospital of Bordeaux - Department of Dermatology
    • Contact: Marie BEYLOT-BARRY, MD, PhD; Phone Number: +335 57 82 25 00; Email: marie.beylot-barry@chu-bordeaux.fr
    • Principal Investigator: Marie BEYLOT-BARRY, MD, PhD
    • Contact: Christine ALFARO; Phone Number: +335 57 82 25 09; Email: christine.alfaro@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with actinic keratosis(AK)	Procedure: skin biopsies; Additional punches of 3 mm from a skin lesion part of a skin biopsy performed as part of routine care, an additional (optional) biopsy of healthy skin
Experimental: patients with squamous cell carcinoma in situ (in situ cSCC)	Procedure: skin biopsies; Additional punches of 3 mm from a skin lesion part of a skin biopsy performed as part of routine care, an additional (optional) biopsy of healthy skin
Experimental: patients with squamous cell carcinomas infiltrative (infiltrative cSCC)	Procedure: skin biopsies; Additional punches of 3 mm from a skin lesion part of a skin biopsy performed as part of routine care, an additional (optional) biopsy of healthy skin
Experimental: patient with invasive metastases (cSCC with cutaneous metastases)	Procedure: skin biopsies; Additional punches of 3 mm from a skin lesion part of a skin biopsy performed as part of routine care, an additional (optional) biopsy of healthy skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue	Evaluation of metabolic changes involved in cSCC progression	Day 1
Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of samples in each category (AK, in situ, ...) that present differentiation features are assessed by immunostaining of loricrin, filaggrin, K10	Evaluation of skin differentiation markers	Day 1
percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index	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.	Day 1
percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test)	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).	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Marie BEYLOT-BARRY, MD, PhD, University Hospital, Bordeaux; Study Chair: Hamid-Reza REZVANI, PhD, Bordeaux Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: mitochondria; metabolism; Cutaneous squamous cell carcinoma; Actinic keratosis,
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: CHUBX 2024/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No