Exploratory Study of Natural Killer Cells in Human Skin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00824889
First received: January 13, 2009
Last updated: May 18, 2010
Last verified: May 2010
  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

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Caroline Gaudy-Marqueste, MD 0491744708 caroline.gaudy@mail.ap-hm.fr

Locations
France
Service de Dermatologie- Hopital Sainte Marguerite Recruiting
Marseille, France, 13385
Contact: Caroline Gaudy-Marqueste, MD    0491744708    caroline.gaudy@mail.ap-hm.fr   
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
ClinicalTrials.gov Identifier: NCT00824889     History of Changes
Other Study ID Numbers: 2008-A00064-51, 2008-03
Study First Received: January 13, 2009
Last Updated: May 18, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis
Dermatitis, Atopic
Graft vs Host Disease
Lichen Planus
Melanoma
Psoriasis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 21, 2014