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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553954
• Other study ID #: SkinAge-1306
• Secondary ID: 2013-A01793-42
• Status: Completed
• Phase: N/A
• Start date: October 7, 2014
• Est. completion date: April 2020

Study information

• Verified date: October 2021
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2020
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Institut de Biologie de Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of senescence markers in healthy skin tissues collected for the two age groups.		Baseline
Secondary	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).		Baseline
Secondary	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.		Baseline
Secondary	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.	Baseline