Other Specified Inflammatory Disorders of Skin or Subcutaneous TissueNEUTROGENENCT01952275
Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases
An observational study of Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue and Pyoderma Gangrenosum, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue, Pyoderma Gangrenosum, Erosive Pustular Dermatosis of the Scalp
- What is being tested?
- Collection of biological samples
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a history of Neutrophil-Mediated Inflammatory Dermatoses (NMID) of any subtype
Who may be able to join
- History of NMID or active disease.
- Informed consent.
Who cannot join
- No consent to either part of the study.
Trial locations and contacts
1 site in 1 country.
Alexander Navarini, MD contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Dept. of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
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
- Conditions
- 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
- Being tested
- Collection of biological samples
- Medical subject headings
- Pyoderma Gangrenosum, Sweet Syndrome, Behcet Syndrome, Acute Generalized Exanthematous Pustulosis, Keratosis, Skin Diseases, Vesiculobullous, Hidradenitis, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Specified Inflammatory Disorders of Skin or Subcutaneous TissueStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Navarini, MD, Principal investigator, University Hospital Zurich, Dept. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952275
- Sponsor's protocol ID
- USZ-DER-AAN-019
- Acronym
- NEUTROGENE
- Status last verified
- Sep 2016
- First submitted
- 17 Sep 2013
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Enrichment of Rare Coding Genetic Variants in Patients Affected by Neutrophil-Mediated Inflammatory Dermatoses
- ClinicalTrials.gov ID
- NCT01952275
- Acronym / sponsor ID
- NEUTROGENE / USZ-DER-AAN-019
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a history of Neutrophil-Mediated Inflammatory Dermatoses (NMID) of any subtype
Key inclusion criteria (2 listed)
- History of NMID or active disease.
- Informed consent.
Key exclusion criteria (1 listed)
- No consent to either part of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological samples | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Navarini, MD contact
Alexander Navarini, MD principal investigator
University Hospital Zurich, Dept. of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Specified Inflammatory Disorders of Skin or Subcutaneous Tissue and Pyoderma Gangrenosum, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Navarini, MD (alexander.navarini@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrichment of rare coding genetic variants (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.