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

October 19, 2021 updated by: Centre Oscar Lambret

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: 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.

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
Baseline

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
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
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Nicolas PENEL, MD, Centre Oscar Lambret
  • Study Director: Olivier PLUQUET, Institut de Biologie de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2014

Primary Completion (Actual)

April 16, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

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)?

NO

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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