Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

Not Applicable

Terminated

• Conditions: Cancer of the Skin
• Interventions: Genetic: Arm A

• Registration Number: NCT01143311
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

The aim of this study is to analyze the differential expression of the miR transcriptome in the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each biopsy and the miRNA profiles will be characterized using a dedicated miR array.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-19
• Status Verified: 2010-06
• Study Start: 2010-06
• Primary Completion: 2010-06
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Study Completion: 2011-04
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patient older than 40th, suffering of a C-SCC
• letter of consent signed by the patient
• to be registered to social security

Exclusion Criteria

• Pregnant women or breastfeeding.
• Small C-SCC (size < 6mm)
• Allergy to Xylocaine
• All vulnerable (minor, adult guardianship...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM A	Arm A	4 distinct biopsies will be taken 1. in a non UV-exposed area (inner arm) 2. in a UV-exposed area (external surface of the forearm) 3. in a pretumoral region (actinic keratosis) 4. inside the tumor

Primary Outcome Measures

Name	Time	Method
miRNAs	1 year	We will select the miRNAs differently expressed between biopsies obtained respectively from areas of normal, pretumoral and tumoral areas (candidate miRs = miRs potentially involved in tumor transformation of epidermal keratinocytes). This will be assessed by analyzing in each of the biopsies from each patient, the expression of different miRs that are known to date, using a dedicated microarray, then by checking the data obtained by quantitative PCR.

Trial Locations

Locations (1)

CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez; 🇫🇷 Nice, Alpes-Maritimes, France