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NCT Number: NCT02553954

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

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of healthy skin tissue

Procedure

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 outcomes

  1. Expression of senescence markers in healthy skin tissues collected for the two age groups.

    Time frame: Baseline

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Institut de Biologie de Lille

Registry information

Official study title

Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues Collected for Two Age Groups.

Acronym: SkinAge

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Sep 18, 2015
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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