Skin CancerStratiKANCT06476964
Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics
A study testing skin biopsies in people with Skin Cancer, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer
- What is being tested?
- skin biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Bordeaux - Department of Dermatology
Bordeaux, 33000
Marie BEYLOT-BARRY, MD, PhD, +335 57 82 25 00, marie.beylot-barry@chu-bordeaux.fr
Christine ALFARO, +335 57 82 25 09, christine.alfaro@chu-bordeaux.fr
About this study
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.
Read the 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.
- Conditions
- Skin Cancer
- Being tested
- skin biopsies
- Keywords
- Actinic keratosis,, Cutaneous squamous cell carcinoma, mitochondria, metabolism
- Medical subject headings
- Skin Neoplasms, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsiesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| patients with actinic keratosis(AK) | Experimental | Not described Receives: Procedure: skin biopsies |
| patients with squamous cell carcinoma in situ (in situ cSCC) | Experimental | Not described Receives: Procedure: skin biopsies |
| patients with squamous cell carcinomas infiltrative (infiltrative cSCC) | Experimental | Not described Receives: Procedure: skin biopsies |
| patient with invasive metastases (cSCC with cutaneous metastases) | Experimental | Not described Receives: Procedure: skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue
Evaluation of metabolic changes involved in cSCC progression
Measured: 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.
Measured: Day 1
Secondary outcomes (3)
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
Measured: 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.
Measured: 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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start4 Jul 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie BEYLOT-BARRY, MD, PhD, Principal investigator, University Hospital, BordeauxHamid-Reza REZVANI, PhD, Study chair, Bordeaux Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476964
- Sponsor's protocol ID
- CHUBX 2024/07
- Acronym
- StratiKA
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratification of Cutaneous Squamous Cell Carcinomas According to Its Transcriptomic, Metabolic and Inflammatory Characteristics
- ClinicalTrials.gov ID
- NCT06476964
- Acronym / sponsor ID
- StratiKA / CHUBX 2024/07
- Conditions
- Skin Cancer
- Keywords
- Actinic keratosis,, Cutaneous squamous cell carcinoma, mitochondria, metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients with actinic keratosis(AK) | Experimental | Procedure: skin biopsies |
| patients with squamous cell carcinoma in situ (in situ cSCC) | Experimental | Procedure: skin biopsies |
| patients with squamous cell carcinomas infiltrative (infiltrative cSCC) | Experimental | Procedure: skin biopsies |
| patient with invasive metastases (cSCC with cutaneous metastases) | Experimental | Procedure: skin biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsiesAdditional 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 | Procedure or surgery | patient with invasive metastases (cSCC with cutaneous metastases), patients with actinic keratosis(AK), patients with squamous cell carcinoma in situ (in situ cSCC), patients with squamous cell carcinomas infiltrative (infiltrative cSCC) |
Primary outcome
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
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.
3 secondary outcomes
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
percentage of samples expressing aggressive markers will be assessed by evaluating the proliferation index
Time frame: Day 1
percentage of samples that are highly proliferative will be calculated by measuring the ability of colony formation (SRB Test)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie BEYLOT-BARRY, MD, PhD principal investigator
University Hospital, Bordeaux
Hamid-Reza REZVANI, PhD study chair
Bordeaux Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsies in people with Skin Cancer, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie BEYLOT-BARRY, MD, PhD (+335 57 82 25 00, marie.beylot-barry@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of metabolite and differential enzyme expression in tumor lesion versus healthy tissue (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024; AzTrials last refreshed its copy on 4 Nov 2026.