Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues (SkinAge).
Primary Purpose
Sarcoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of healthy skin tissue
Sponsored by
About this trial
This is an interventional other trial for Sarcoma focused on measuring Mechanisms of Senescence, Senescence markers
Eligibility 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
Sites / Locations
- Centre Oscar Lambret
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Collection of healthy skin tissue
Arm Description
Collection of healthy skin tissue
Outcomes
Primary Outcome Measures
Expression of senescence markers in healthy skin tissues collected for the two age groups.
Secondary Outcome Measures
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).
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.
Morbidity
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.
Full Information
NCT ID
NCT02553954
First Posted
September 17, 2015
Last Updated
October 19, 2021
Sponsor
Centre Oscar Lambret
Collaborators
Institut de Biologie de Lille
1. Study Identification
Unique Protocol Identification Number
NCT02553954
Brief Title
Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues (SkinAge).
Official Title
Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues Collected for Two Age Groups.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 7, 2014 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Institut de Biologie de Lille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Mechanisms of Senescence, Senescence markers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collection of healthy skin tissue
Arm Type
Experimental
Arm Description
Collection of healthy skin tissue
Intervention Type
Procedure
Intervention Name(s)
Collection of healthy skin tissue
Intervention Description
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 Measure Information:
Title
Expression of senescence markers in healthy skin tissues collected for the two age groups.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Morbidity
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas PENEL, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olivier PLUQUET
Organizational Affiliation
Institut de Biologie de Lille
Official's Role
Study Director
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues (SkinAge).
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