Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis

This study has been completed.

Sponsor:

Information provided by:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT00822250

First received: January 13, 2009

Last updated: October 20, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 13, 2009
Last Updated Date	October 20, 2010
Start Date ^ICMJE	April 2008
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 3, 2009)	to determine molecular mechanism of the disease [ Time Frame: at time= 0 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: January 13, 2009)	to determine molecular mecanism of the disease [ Time Frame: at time= 0 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00822250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 13, 2009)	to research relationship between skin phenotype and cystinosis [ Time Frame: at time =0 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis
Official Title ^ICMJE	Clinical and Biological Study of Sub-pigmentation During Infantile Cystinosis
Brief Summary	The purpose of this study is to determine the molecular mechanism of this disease and to research the relationship between cystinosis and skin phenotype.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Cystinosis
Intervention ^ICMJE	Other: analysis of pigmentation cutting hair, skin description, skin biopsy for only 4 patients Other Names: surgical biopsy skin examination
Study Arm (s)	1 cutting hair, skin phenotype description Intervention: Other: analysis of pigmentation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	30
Completion Date	December 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: cystinosis known CTNS mutation Exclusion Criteria: patient with corticotherapy treatment patient with immunosuppressant treatment
Gender	Both
Ages	1 Year to 15 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00822250
Other Study ID Numbers ^ICMJE	07-PP-05
Has Data Monitoring Committee	No
Responsible Party	Département de la Recherche Clinique et de l'Innovation, CHU de Nice
Study Sponsor ^ICMJE	Centre Hospitalier Universitaire de Nice
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre Hospitalier Universitaire de Nice
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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