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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06476964
Acronym
StratiKA
Enrollment
200
Registered
2024-06-27
Start date
2024-07-04
Completion date
2026-07-31
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer

Keywords

Actinic keratosis,, Cutaneous squamous cell carcinoma, mitochondria, metabolism

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.

Interventions

PROCEDUREskin 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

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissueDay 1Evaluation of metabolic changes involved in cSCC progression
Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.Day 1Characterization 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.

Secondary

MeasureTime frameDescription
percentage of samples in each category (AK, in situ, ...) that present differentiation features are assessed by immunostaining of loricrin, filaggrin, K10Day 1Evaluation of skin differentiation markers
percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation indexDay 1Evaluation 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 1Evaluation 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).

Countries

France

Contacts

Primary ContactMarie BEYLOT-BARRY, MD, PhD
marie.beylot-barry@chu-bordeaux.fr+335 57 82 25 00
Backup ContactChristine ALFARO
christine.alfaro@chu-bordeaux.fr+335 57 82 25 09

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026