Exploratory Study of Natural Killer Cells in Human Skin - Full Text View

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00824889

Purpose

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.

Condition	Intervention
Atopic Dermatitis Contact Dermatitis Psoriasis Lichen Planus Graft Versus Host Disease Melanoma	Other: Biopsy and sample of blood

MedlinePlus related topics: Melanoma Psoriasis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Parallel Assignment
Official Title:	Exploratory Study of Natural Killer Cells in Human Skin

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:

100

Arms	Assigned Interventions
1 Healthy volunteer	Other: Biopsy and sample of blood Biopsy and sample of blood
2 atopic dermatitis patient	Other: Biopsy and sample of blood Biopsy and sample of blood
3 contact dermatitis patient	Other: Biopsy and sample of blood Biopsy and sample of blood
4 psoriasis patient	Other: Biopsy and sample of blood Biopsy and sample of blood
5 lichen planus patient	Other: Biopsy and sample of blood Biopsy and sample of blood
6 GVH patient	Other: Biopsy and sample of blood Biopsy and sample of blood
7 melanoma patient	Other: Biopsy and sample of blood Biopsy and sample of blood

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824889

Locations

France
Service de Dermatologie- Hopital Sainte Marguerite
MARSEILLE, France, 13385

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Caroline Gaudy-Marqueste, MD

Assistance Publique des Hopitaux de Marseille

More Information

No publications provided

Responsible Party:	Assistance Publique Hopitaux De Marseille ( Assistance Publique Hopitaux De Marseille )
Study ID Numbers:	2008-A00064-51, 2008-03
Study First Received:	January 13, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00824889 History of Changes
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Lichen Planus
Dermatitis, Atopic
Skin Diseases
Dermatitis, Contact
Homologous Wasting Disease
Neuroendocrine Tumors
Melanoma
Graft Versus Host Disease
Neuroectodermal Tumors
Exanthema
Hypersensitivity
Genetic Diseases, Inborn

Psoriasis
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Hypersensitivity, Immediate
Neuroepithelioma
Graft vs Host Disease
Skin Diseases, Eczematous
Nevus
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Lichen Planus
Neoplasms by Histologic Type
Dermatitis, Atopic
Immune System Diseases
Skin Diseases
Neoplasms, Nerve Tissue
Dermatitis, Contact
Neuroendocrine Tumors
Melanoma
Neuroectodermal Tumors
Neoplasms
Hypersensitivity

Genetic Diseases, Inborn
Psoriasis
Neoplasms, Germ Cell and Embryonal
Hypersensitivity, Immediate
Graft vs Host Disease
Skin Diseases, Eczematous
Nevi and Melanomas
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009