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Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo - INNATE Vitiligo (INNATEvitiligo)

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ClinicalTrials.gov Identifier: NCT03859518
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date February 26, 2019
First Posted Date March 1, 2019
Last Update Posted Date December 9, 2019
Actual Study Start Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2019)
  • study the presence and type of ILC and NK in the blood and skin [ Time Frame: 1 day ]
    Compare vitiligo patients to control subjects.
  • study the presence and type of ILC and NK in the skin [ Time Frame: 1 day ]
    Compare vitiligo patients to control subjects.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo - INNATE Vitiligo
Official Title Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo
Brief Summary The cohort included only major patients with non-segmental vitiligo and no other autoimmune or inflammatory associated diseases (except thyroiditis). Control subjects should have no autoimmune or inflammatory diseases. Patients and controls should not take treatment with corticosteroids or other potentially immunomodulatory therapies. Patients and controls are recruited in the Dermatology Department of the University Hospital of Nice and the Hospital of Fréjus. The investigators have already initiated the collection of tissues and blood from patients and control subjects and we have succeeded in isolating ILCs and NKs from a blood volume of 50ml. We were able to sort the ILC subpopulations. Early data suggest an increase in Natural Killer (NK) and Innate Lymphoïdes Cells 1 (ILC1) in the blood of vitiligo patients compared to control subjects. The investigators also managed to extract the melanocytes from the skin biopsies of the first patients and control subjects.
Detailed Description The investigators want study the presence and type of ILC and NK in the blood and skin of vitiligo patients compared to control subjects.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

in this study, there are 2 groups. First with vitiligo and the second only with control subjects without autoimmune or inflammatory diseases.

All this subjects were include in the dermatolgy servive of the CHU of Nice.

Condition Vitiligo
Intervention Other: blood and skin samples
To study the presence and type of ILC and NK in the blood and skin of vitiligo patients compared to control subjects.
Study Groups/Cohorts
  • patients with Vitiligo
    Intervention: Other: blood and skin samples
  • control
    Intervention: Other: blood and skin samples
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 27, 2019)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2019
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

vitiligo subjects :

  • patients in the cohort with non-segmental vitiligo
  • without other autoimmune or inflammatory diseases associated

control subjects :

  • subject without autoimmune or inflammatory disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03859518
Other Study ID Numbers 18-GIRCI-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor Centre Hospitalier Universitaire de Nice
Collaborators Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Thierry PASSERON, MD; PhD Centre Hospitalier Universitaire de Nice
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date January 2019