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Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143311
First Posted: June 14, 2010
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire de Nice
  Purpose
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 Intervention
Cancer of the Skin Genetic: Arm A

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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…)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143311


Locations
France
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
  More Information

Responsible Party: CAILLON Cynthia, DRCI du CHU de Nice
ClinicalTrials.gov Identifier: NCT01143311     History of Changes
Other Study ID Numbers: 09-PP-05
First Submitted: April 19, 2010
First Posted: June 14, 2010
Last Update Posted: June 1, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases