Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues (SkinAge).
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|ClinicalTrials.gov Identifier: NCT02553954|
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : October 20, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Procedure: Collection of healthy skin tissue||Not Applicable|
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues Collected for Two Age Groups.|
|Actual Study Start Date :||October 7, 2014|
|Actual Primary Completion Date :||April 16, 2019|
|Actual Study Completion Date :||April 2020|
Experimental: Collection of healthy skin tissue
Collection of healthy skin tissue
Procedure: Collection of healthy skin tissue
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.
- Expression of senescence markers in healthy skin tissues collected for the two age groups. [ Time Frame: Baseline ]
- 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 ]
- 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 ]
- Morbidity [ Time Frame: Baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553954
|Centre Oscar Lambret|
|Lille, France, 59020|
|Study Chair:||Nicolas PENEL, MD||Centre Oscar Lambret|
|Study Director:||Olivier PLUQUET||Institut de Biologie de Lille|