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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01952275
Other study ID # USZ-DER-AAN-019
Secondary ID
Status Recruiting
Phase N/A
First received September 17, 2013
Last updated September 26, 2016
Start date January 2014
Est. completion date January 2020

Study information

Verified date September 2016
Source University of Zurich
Contact Alexander Navarini, MD
Email alexander.navarini@usz.ch
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

This study investigates the genetic architecture of Neutrophil-Mediated Inflammatory Skin Diseases. After collecting informed consent, all patients' clinical phenotype is graded at inclusion with a detailed case report form and a discovery cohort formed based on the certainty of diagnosis. The DNA of patients in the discovery cohort is analyzed by whole exome sequencing which identifies all protein-coding genetic variants. Subsequently, statistical burden tests are going to identify enrichment of rare coding genetic variants in patients affected by Neutrophil-Mediated Inflammatory Skin Diseases.

The ultimate goal is to reveal the responsible gene(s) that may then be targets for clinical intervention.


Description:

Timeframe:

- Collection of DNA for discovery cohort until 05/2016

- Data analysis until 12/2014 for pyoderma gangrenosum, until 12/2016 for other NMID

- Report and data presentation early 2015 for PG, 2017 for other NMID


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Both
Age group N/A to 120 Years
Eligibility Inclusion criteria:

- History of NMID or active disease.

- Informed consent.

Exclusion criteria:

- No consent to either part of the study.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Acute Generalized Exanthematous Pustulosis
  • Amicrobial Pustulosis of the Folds
  • Behcet Syndrome
  • Behcet's Disease
  • Bowel-associated Dermatosis-arthritis Syndrome
  • Bullous Systemic Lupus Erythematosus
  • Dermatitis
  • Dermatitis Herpetiformis
  • Epidermolysis Bullosa
  • Epidermolysis Bullosa Acquisita
  • Erosive Pustular Dermatosis of the Scalp
  • Erythema
  • Erythema Elevatum Diutinum
  • Erythema Marginatum
  • Familial Mediterranean Fever
  • Hidradenitis
  • IgA Pemphigus
  • Infantile Acropustulosis
  • Inflammatory Epidermolysis Bullosa Aquisita
  • Keratoderma Blenorrhagicum
  • Keratosis
  • Linear IgA Bullous Dermatosis
  • Lupus Erythematosus, Systemic
  • Medium Vessel Vasculitis
  • Neutrophilic Dermatosis of the Dorsal Hands (Pustular Vasculitis)
  • Neutrophilic Eccrine Hidradenitis
  • Neutrophilic Urticaria
  • Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue
  • Pemphigus
  • Psoriasis
  • Pustular Psoriasis
  • Pyoderma
  • Pyoderma Gangrenosum
  • Rheumatoid Neutrophilic Dermatitis
  • Skin Diseases
  • Small Vessel Vasculitis Including Urticarial Vasculitis
  • Sneddon-Wilkinson Disease
  • Still's Disease
  • Sweet's Syndrome
  • Syndrome
  • Transient Neonatal Pustulosis
  • Unclassified Periodic Fever Syndromes / Autoinflammatory Syndromes
  • Urticaria
  • Vasculitis

Intervention

Procedure:
Collection of biological samples


Locations

Country Name City State
Switzerland University Hospital Zurich, Dept. of Dermatology Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Enrichment of rare coding genetic variants Whole exome sequencing is going to detect rare coding genetic variants in cases of Neutrophil-Mediated Inflammatory Skin Diseases. Statistical burden tests are applied to test for excess of rare variants in cases versus available controls of matching ancestry. baseline No
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