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Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues (SkinAge).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02553954
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
Institut de Biologie de Lille
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Expression of senescence markers in healthy skin tissues collected for the two age groups. [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Institut de Biologie de Lille
Investigators
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Study Chair: Nicolas PENEL, MD Centre Oscar Lambret
Study Director: Olivier PLUQUET Institut de Biologie de Lille
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02553954    
Other Study ID Numbers: SkinAge-1306
2013-A01793-42 ( Other Identifier: ANSM )
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
Mechanisms of Senescence
Senescence markers
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms