Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

NCT ID: NCT01143311

Last Updated: 2011-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer of the Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Arm A

Intervention Type 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

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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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…)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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DRCI du CHU de Nice

Principal Investigators

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Thierry Passeron, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nice, Alpes-Maritimes, France

Site Status

Countries

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France

Other Identifiers

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09-PP-05

Identifier Type: -

Identifier Source: org_study_id

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