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Trial Title:
Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics
NCT ID:
NCT06476964
Condition:
Skin Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Conditions: Keywords:
Actinic keratosis,
Cutaneous squamous cell carcinoma
mitochondria
metabolism
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
skin biopsies
Description:
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
Arm group label:
patient with invasive metastases (cSCC with cutaneous metastases)
Arm group label:
patients with actinic keratosis(AK)
Arm group label:
patients with squamous cell carcinoma in situ (in situ cSCC)
Arm group label:
patients with squamous cell carcinomas infiltrative (infiltrative cSCC)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital of Bordeaux - Department of Dermatology
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie BEYLOT-BARRY, MD, PhD
Phone:
+335 57 82 25 00
Email:
marie.beylot-barry@chu-bordeaux.fr
Contact backup:
Last name:
Christine ALFARO
Phone:
+335 57 82 25 09
Email:
christine.alfaro@chu-bordeaux.fr
Investigator:
Last name:
Marie BEYLOT-BARRY, MD, PhD
Email:
Principal Investigator
Start date:
July 4, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Collaborator:
Agency:
Institut National de la Santé Et de la Recherche Médicale, France
Agency class:
Other
Source:
University Hospital, Bordeaux
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06476964
