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NCT00824889 Clinical Trial

Exploratory Study of Natural Killer Cells in Human Skin

Melanoma Clinical Trial

Official title:
Exploratory Study of Natural Killer Cells in Human Skin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00824889
Other study ID # 2008-A00064-51
Secondary ID 2008-03
Status Completed
Phase N/A
First received January 13, 2009
Last updated August 28, 2014
Start date February 2009
Est. completion date November 2011

Study information
Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.

Description:

Then, we will define whether these parameters are qualitatively/ quantitatively modified in the following skin pathologies: a) atopic dermatitis; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH (graft versus host disease) ; (f) melanoma.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age = 18 years.

- Consent obtained after healthy donor or patient information.

- Patients suffering from one of the following diseases: a) atopic dermatitis ; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH ; f) melanoma.

Exclusion Criteria:

- Age below 18,

- pregnant or breastfeeding women,

- persons under guardianship, persons without social security, prisoners, persons hospitalized without consent on the basis of French laws L. 3212-1 et L. 3213-1. Patients affected by HIV infection, AIDS, Hepatitis A, B or C infection.

- Neutropenia <1000/mm3.

- Thrombopenia <50 000/mm3.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• Biopsy and sample of blood
Biopsy and sample of blood
• Biopsy and sample of blood
Biopsy and sample of blood
• Biopsy and sample of blood
Biopsy and sample of blood
• Biopsy and sample of blood
Biopsy and sample of blood
• Biopsy and sample of blood
Biopsy and sample of blood
• Biopsy and sample of blood
Biopsy and sample of blood
• Biopsy and sample of blood
Biopsy and sample of blood

Locations
Country Name City State
France Service de Dermatologie- Hopital Sainte Marguerite Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin. 12 months No
Secondary To determine whether the eventual modifications detected in skin pathologies are correlated to qualitative/ quantitative alterations of NK cell subsets present in the peripheral blood. 12 months No
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