- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02553954
Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues (SkinAge).
Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues Collected for Two Age Groups.
Epidemiological data show that the incidence of carcinoma, the most common cancer, is strongly linked to the age. Non Melanoma Skin Carcinomas (NMSCs) (the most frequent cancers in the elderly population) derive from keratinocytes of the basal layer of the epidermis, from differentiated keratinocytes of the more superficial layers or from stem cells of hair follicles. Unlike NMSCs, soft-tissue sarcomas, including those deriving from dermal fibroblasts, are very rare (less than 1% of all cancers). Our overall purpose is to decipher the molecular pathways activated during the aging of these tissues that may explain why they have a so different propensity to undergo a malignant transformation. Given that senescent cells accumulate in the dermis and epidermis with age, we will constitute two groups : "young skin" that we arbitrarily limit to the range ≥ 18 and ≤ 40 and "aged skin" ≥ 55.
Thus the main objective of our study is to search within 2 age groups (≥ 18 and ≤ 40 years and ≥ 55 years) the expression of senescence markers on healthy skin tissue.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Information and obtaining informed consent.
- Collection of clinical data.
- Collection of two samples of healthy skin tissue, without disfigurement, during an intervention under general anesthesia for the treatment of a sarcoma.
- Freezing samples of healthy skin tissue in liquid nitrogen within 10 minutes after collection.
- Transfer of the samples to the laboratory of anatomopathology.
- Preparation of the healthy skin samples by the laboratory of anatomopathology.
- Transfer of the conditioned samples to the Institut de Biologie de Lille for analysis.
- Control of the aesthetic appearance during the postoperative consultation.
- Destruction of the samples at the end of analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lille, France, 59020
- Centre Oscar Lambret
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient with an operable sarcoma
- Requiring a surgical operation under general anesthesia at the Oscar Lambret Centre
- Age ≥ 18 ans, belonging to one of the two following age groups : [ ≥ 18 and ≤ 40 years] and [ ≥ 55 years]
- Patient having a social security scheme
- Patient having signed an informed consent form for the study
Exclusion Criteria:
- Patient aged under 18 or between 41 and 54
- Location of the tumor on the face, neck or neckline
- Patient with a skin tumor
- Tumor-induced cutaneous fistula making suspect a tumor invasion of the skin
- Patient with a chronic skin disease
- Collection in an area already treated by surgery, radiotherapy or brachytherapy
- Pregnant or breastfeeding women
- Patient under guardianship or tutorship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Collection of healthy skin tissue
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Collection of two samples of healthy skin tissue, without disfigurement, during an intervention under general anesthesia for the treatment of a benign or malignant tumor.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Expression of senescence markers in healthy skin tissues collected for the two age groups.
Time Frame: Baseline
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Research of emerging cells in the skin tissue of the subjects of the two age groups via the expression of the Protease-Activated Receptor-1 (PAR-1).
Time Frame: Baseline
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Baseline
|
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Presence of different types of DNA damage (single and double strand breaks) in the keratinocytes and fibroblasts of the skin tissues of the two age groups.
Time Frame: Baseline
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Baseline
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Morbidity
Time Frame: Baseline
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Postoperative complications up to 30 days after surgery according to the Clavien-Dindo classification (2009), according to the NCI-CTCAE v4.0 beyond this deadline.
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Nicolas PENEL, MD, Centre Oscar Lambret
- Study Director: Olivier PLUQUET, Institut de Biologie de Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SkinAge-1306
- 2013-A01793-42 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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