- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01952275
Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases (NEUTROGENE)
Assessment of the Enrichment of Rare Coding Genetic Variants in Patients Affected by Neutrophil-Mediated Inflammatory Dermatoses
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.
Study Overview
Status
Conditions
- Pustular Psoriasis
- Erosive Pustular Dermatosis of the Scalp
- Behcet's Disease
- Dermatitis Herpetiformis
- Pyoderma Gangrenosum
- Linear IgA Bullous Dermatosis
- Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue
- Sweet's Syndrome
- Bowel-associated Dermatosis-arthritis Syndrome
- Acute Generalized Exanthematous Pustulosis
- Keratoderma Blenorrhagicum
- Sneddon-Wilkinson Disease
- IgA Pemphigus
- Amicrobial Pustulosis of the Folds
- Infantile Acropustulosis
- Transient Neonatal Pustulosis
- Neutrophilic Eccrine Hidradenitis
- Rheumatoid Neutrophilic Dermatitis
- Neutrophilic Urticaria
- Still's Disease
- Erythema Marginatum
- Unclassified Periodic Fever Syndromes / Autoinflammatory Syndromes
- Bullous Systemic Lupus Erythematosus
- Inflammatory Epidermolysis Bullosa Aquisita
- Neutrophilic Dermatosis of the Dorsal Hands (Pustular Vasculitis)
- Small Vessel Vasculitis Including Urticarial Vasculitis
- Erythema Elevatum Diutinum
- Medium Vessel Vasculitis
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alexander Navarini, MD
- Email: alexander.navarini@usz.ch
Study Locations
-
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ZH
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Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich, Dept. of Dermatology
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- History of NMID or active disease.
- Informed consent.
Exclusion criteria:
- No consent to either part of the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrichment of rare coding genetic variants
Time Frame: baseline
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander Navarini, MD, University Hospital Zurich, Dept. of Dermatology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Sweat Gland Diseases
- Immune System Diseases
- Autoimmune Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Disease
- Congenital Abnormalities
- Skin Ulcer
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Hypersensitivity
- Skin Manifestations
- Skin Abnormalities
- Drug-Related Side Effects and Adverse Reactions
- Drug Eruptions
- Drug Hypersensitivity
- Syndrome
- Lupus Erythematosus, Systemic
- Behcet Syndrome
- Dermatitis
- Erythema
- Skin Diseases
- Hidradenitis
- Vasculitis
- Urticaria
- Epidermolysis Bullosa
- Pyoderma
- Skin Diseases, Vesiculobullous
- Pemphigus
- Dermatitis Herpetiformis
- Pyoderma Gangrenosum
- Linear IgA Bullous Dermatosis
- Epidermolysis Bullosa Acquisita
- Acute Generalized Exanthematous Pustulosis
- Sweet Syndrome
Other Study ID Numbers
- USZ-DER-AAN-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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