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

NCT ID: NCT06476964

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-04

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Skin Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients with actinic keratosis(AK)

Group Type EXPERIMENTAL

skin biopsies

Intervention Type 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

patients with squamous cell carcinoma in situ (in situ cSCC)

Group Type EXPERIMENTAL

skin biopsies

Intervention Type 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

patients with squamous cell carcinomas infiltrative (infiltrative cSCC)

Group Type EXPERIMENTAL

skin biopsies

Intervention Type 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

patient with invasive metastases (cSCC with cutaneous metastases)

Group Type EXPERIMENTAL

skin biopsies

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie BEYLOT-BARRY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Hamid-Reza REZVANI, PhD

Role: STUDY_CHAIR

Bordeaux Institute of Oncology

Locations

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University Hospital of Bordeaux - Department of Dermatology

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie BEYLOT-BARRY, MD, PhD

Role: CONTACT

+335 57 82 25 00

Christine ALFARO

Role: CONTACT

+335 57 82 25 09

Facility Contacts

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Marie BEYLOT-BARRY, MD, PhD

Role: primary

+335 57 82 25 00

Christine ALFARO

Role: backup

+335 57 82 25 09

Other Identifiers

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CHUBX 2024/07

Identifier Type: -

Identifier Source: org_study_id

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