Exploratory Study of Natural Killer Cells in Human Skin

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Completed

CT.gov ID

NCT00824889

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Contact Dermatitis Psoriasis Lichen Planus Graft Versus Host Disease Melanoma	Other: Biopsy and sample of blood Other: Biopsy and sample of blood Other: Biopsy and sample of blood Other: Biopsy and sample of blood Other: Biopsy and sample of blood Other: Biopsy and sample of blood Other: Biopsy and sample of blood	N/A

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 ;

lichen planus ; e) GVH (graft versus host disease) ; (f) melanoma.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Exploratory Study of Natural Killer Cells in Human Skin

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 Healthy volunteer	Other: Biopsy and sample of blood Biopsy and sample of blood
Other: 2 atopic dermatitis patient	Other: Biopsy and sample of blood Biopsy and sample of blood
Other: 3 contact dermatitis patient	Other: Biopsy and sample of blood Biopsy and sample of blood
Other: 4 psoriasis patient	Other: Biopsy and sample of blood Biopsy and sample of blood
Other: 5 lichen planus patient	Other: Biopsy and sample of blood Biopsy and sample of blood
Other: 6 GVH patient	Other: Biopsy and sample of blood Biopsy and sample of blood
Other: 7 melanoma patient	Other: Biopsy and sample of blood Biopsy and sample of blood

Outcome Measures

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. [12 months]

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. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.