Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

Cancer of the Skin Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01143311
• Other study ID #: 09-PP-05
• Status: Terminated
• Phase: N/A
• First received: April 19, 2010
• Last updated: May 31, 2011
• Start date: June 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2010
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cancer of the Skin
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez	Nice	Alpes-Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No