Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Terminated

CT.gov ID

NCT01143311

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Skin	Genetic: Arm A	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: ARM A 4 distinct biopsies will be taken in a non UV-exposed area (inner arm) in a UV-exposed area (external surface of the forearm) in a pretumoral region (actinic keratosis) inside the tumor	Genetic: Arm A 4 distinct biopsies will be taken in a non UV-exposed area (inner arm) in a UV-exposed area (external surface of the forearm) in a pretumoral region (actinic keratosis) inside the tumor

Arm

Intervention/Treatment

Other: ARM A

4 distinct biopsies will be taken in a non UV-exposed area (inner arm) in a UV-exposed area (external surface of the forearm) in a pretumoral region (actinic keratosis) inside the tumor

Genetic: Arm A

4 distinct biopsies will be taken in a non UV-exposed area (inner arm) in a UV-exposed area (external surface of the forearm) in a pretumoral region (actinic keratosis) inside the tumor

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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…)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez	Nice	Alpes-Maritimes	France	06001

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: Thierry Passeron, PhD, CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01143311

Other Study ID Numbers:

09-PP-05

First Posted:

Jun 14, 2010

Last Update Posted:

Jun 1, 2011

Last Verified:

Jun 1, 2010

Additional relevant MeSH terms:

Skin Neoplasms

Study Results

No Results Posted as of Jun 1, 2011