Exploratory Study of Natural Killer Cells in Human Skin
2 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2009
CompletedFirst Posted
Study publicly available on registry
January 19, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedAugust 29, 2014
August 1, 2014
2.7 years
January 13, 2009
August 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (7)
1
OTHERHealthy volunteer
2
OTHERatopic dermatitis patient
3
OTHERcontact dermatitis patient
4
OTHERpsoriasis patient
5
OTHERlichen planus patient
6
OTHERGVH patient
7
OTHERmelanoma patient
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Dermatologie- Hopital Sainte Marguerite
Marseille, 13385, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline Gaudy-Marqueste, MD
Assistance Publique des Hopitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2009
First Posted
January 19, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
August 29, 2014
Record last verified: 2014-08