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Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

Primary Purpose

Cancer of the Skin

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arm A
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cancer of the Skin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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…)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ARM A

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2010
Last Updated
May 31, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01143311
Brief Title
Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Skin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM A
Arm Type
Other
Arm Description
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
Intervention Type
Genetic
Intervention Name(s)
Arm A
Intervention Description
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
Primary Outcome Measure Information:
Title
miRNAs
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Passeron, PhD
Organizational Affiliation
CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France

12. IPD Sharing Statement

Learn more about this trial

Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

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