Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

May 31, 2011 updated by: Centre Hospitalier Universitaire de Nice
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Genetic: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miRNAs
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-PP-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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