ClinicalTrials.gg
Status unknownNCT01952275NEUTROGENEUpdated Sep 27, 2016

Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases

An observational study in Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue, Pyoderma Gangrenosum and Erosive Pustular Dermatosis of the Scalp, sponsored by University of Zurich. Status unknown at 1 site in Switzerland. Open to participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by University of Zurich · Observational

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
600
Ages
Up to 120 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue
  • Pyoderma Gangrenosum
  • Erosive Pustular Dermatosis of the Scalp
  • Sweet's Syndrome
  • Behcet's Disease
  • Bowel-associated Dermatosis-arthritis Syndrome
  • Pustular Psoriasis
  • 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
  • Dermatitis Herpetiformis
  • Linear IgA Bullous Dermatosis
  • 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
03

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a history of Neutrophil-Mediated Inflammatory Dermatoses (NMID) of any subtype

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • History of NMID or active disease.
  • .

Exclusion criteria

Exclusion criteria:

  • No consent to either part of the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • ProcedureCollection of biological samples
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • University Hospital Zurich, Dept. of Dermatology
    Zurich, ZH 8091, Switzerland
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01952275
Responsible party
Sponsor
First posted
Sep 27, 2013
Start date
Jan 2014
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Sep 27, 2016

Study contacts

Alexander Navarini, MD
Contact
alexander.navarini@usz.ch
Alexander Navarini, MD
principal investigator · University Hospital Zurich, Dept. of Dermatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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