Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

NCT01143311 | Terminated

• 1 other identifier: 09-PP-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of the Skin

Outcome Measures

Primary Outcomes (1)

• miRNAs

  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.

  1 year

Study Arms (1)

ARM A

OTHER

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

Genetic: Arm A

Interventions

Arm A GENETIC

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

ARM A

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thierry Passeron, PhD

  CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: June 14, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2010-06

Locations

FR (1)