NCT02553954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

September 17, 2015

Last Update Submit

March 16, 2026

Conditions

Keywords

Mechanisms of SenescenceSenescence markers

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Secondary Outcomes (3)

  • 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

  • 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

  • Morbidity

    Baseline

Study Arms (1)

Collection of healthy skin tissue

EXPERIMENTAL

Collection of healthy skin tissue

Procedure: Collection of healthy skin tissue

Interventions

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.

Collection of healthy skin tissue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Nicolas PENEL, MD

    Centre Oscar Lambret

    STUDY CHAIR
  • Olivier PLUQUET

    Institut de Biologie de Lille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 18, 2015

Study Start

October 7, 2014

Primary Completion

April 16, 2019

Study Completion

April 1, 2020

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations