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Clinical Transcriptomics in Systemic Vasculitis (CUTIS) (CUTIS)

This study is currently recruiting participants.
Verified October 2017 by Peter Merkel, University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT03004326
First Posted: December 28, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Science (NCATS)
Office of Rare Diseases Research (ORDR)
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
  Purpose
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.

Condition
Cryoglobulinemic Vasculitis (CV) Drug-induced Vasculitis Eosinophilic Granulomatosis With Polyangiitis (EGPA) IgA Vasculitis Isolated Cutaneous Vasculitis Granulomatosis With Polyangiitis (GPA) Microscopic Polyangiitis (MPA) Polyarteritis Nodosa (PAN) Urticarial Vasculitis Vasculitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Resource links provided by NLM:


Further study details as provided by Peter Merkel, University of Pennsylvania:

Primary Outcome Measures:
  • Evaluation of clinical data and linked biopsy specimens [ Time Frame: 1 year ]
    Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.


Biospecimen Retention:   Samples With DNA
Blood samples will be collected solely for research purposes. The reason we are performing these laboratory-based research studies is to help us better understand whether abnormalities detected in a subjects skin biopsy can also be detected in their blood.

Estimated Enrollment: 50
Actual Study Start Date: January 2017
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Detailed Description:

This study employs a multi-center approach to evaluate cutaneous vasculitis across several forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be evaluated by teams of primary vasculitis care providers and Dermatologists in order to facilitate optimal selection of patients and sampling of lesions.

A punch skin biopsy at a site of active vasculitis will be the source of material for histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis will be characterized using a standardized approach.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

About 56 people with vasculitis will take part in this study at approximately 20 medical centers across North America. Patients with CV, DiV, EGPA, IgA vasculitis, GPA, MPA, PAN, isolated cutaneous vasculitis and urticarial vasculitis will potentially be enrolled into this study.

The protocol will be conducted at the major vasculitis centers in the United States and Canada participating in selected VCRC studies. Skin biopsy specimens collected as standard of care for these diseases will be retrieved and used in research.

Criteria

Inclusion Criteria:

  • Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis
  • Have a suspected or confirmed diagnosis of:

    • Cryoglobulinemic vasculitis (CV)
    • Drug-induced vasculitis
    • Eosinophilic granulomatosis with polyangiitis (EGPA)
    • IgA vasculitis
    • Isolated cutaneous vasculitis
    • Granulomatosis with polyangiitis (GPA)
    • Microscopic polyangiitis (MPA)
    • Polyarteritis nodosa (PAN)
    • Urticarial vasculitis
  • Be willing and able to provide written informed consent (or assent for those under

Exclusion Criteria:

  • You are less than five years old
  • Considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for you participating in this study do not outweigh the potential benefit of learning information from your biopsy
  • You have a neutrophil count (type of white blood cell) less than 1500/mm3, platelet count less than 50,000/mm3, or a hemoglobin less than 7 g/dL
  • You have an uncontrolled disease that could prevent you from completing the study procedures
  • You have an active infection at or near the potential biopsy site, have poor circulation, or have bony prominence or other structure that would increase your risk of complications if you participated in this study
  • You are pregnant or nursing
  • You are not able to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004326


Contacts
Contact: Carol McAlear, MA cmcalear@upenn.edu

Locations
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Britte Beaudette-Zlatanova       britte@bu.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Katrina Pierce       pierce.katrina@mayo.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michelle Hampton       michelle.hampton@uphs.upenn.edu   
Sponsors and Collaborators
Peter Merkel
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Science (NCATS)
Office of Rare Diseases Research (ORDR)
Investigators
Principal Investigator: Robert Micheletti, MD University of Pennsylvania
Principal Investigator: Peter Grayson, MD, MSc The National Institute of Arthritis and Musculoskeletal and Skin Diseases
  More Information

Additional Information:
Responsible Party: Peter Merkel, Chief, Division of Rheumatology Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03004326     History of Changes
Other Study ID Numbers: VCRC5563
U54AR057319 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2016
First Posted: December 28, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Peter Merkel, University of Pennsylvania:
DIV
CSS
EGPA
HSP
GPA
MPA
PAN
Wegeners

Additional relevant MeSH terms:
Vasculitis
Systemic Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Polyarteritis Nodosa
Churg-Strauss Syndrome
Cryoglobulinemia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arteritis
Skin Diseases, Vascular
Skin Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Hemostatic Disorders
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases