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NCT Number: NCT06476964

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin biopsies

Procedure

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

Primary outcomes

  1. Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue

    Time frame: Day 1

    Evaluation of metabolic changes involved in cSCC progression

  2. Percentages of individual immune cell populations among total tumor-infiltrating immune cells will be evaluated.

    Time frame: 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.

Secondary outcomes

  1. percentage of samples in each category (AK, in situ, ...) that present differentiation features are assessed by immunostaining of loricrin, filaggrin, K10

    Time frame: Day 1

    Evaluation of skin differentiation markers

  2. percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index

    Time frame: 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.

  3. percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Christine ALFARO

CONTACT

[email protected]

+335 57 82 25 09

Marie BEYLOT-BARRY, MD, PhD

CONTACT

[email protected]

+335 57 82 25 00

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: StratiKA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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