5563: Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Status: Recruiting

The purpose of this study is to take skin biopsy samples from participants with skin (cutaneous) vasculitis to see what vasculitis is doing to the skin. The doctors in this study would like to describe the impact of vasculitis on the skin and to investigate the differences between the different types of skin vasculitis. The research team hopes that this study will develop information about skin vasculitis that will allow researchers to learn about the causes, the disease process and potential treatments for skin vasculitis.

For Diseases

  • Cryoglobulinemic vasculitis (CV)
  • Drug-induced vasculitis
  • Eosinophilic granulomatosis with polyangiitis (EGPA)
  • Granulomatosis with polyangiitis (GPA)
  • IgA vasculitis
  • Isolated cutaneous vasculitis
  • Microscopic polyangiitis (MPA)
  • Polyarteritis nodosa (PAN)
  • Urticarial vasculitis

Background

Vasculitis is the swelling or inflammation of your blood vessels. There are many forms of vasculitis, and the cause is unknown for most types of vasculitis. Vasculitis can be isolated to a single body part, or it can involve many different parts of the body. Vasculitis frequently affects the skin and causes different kinds of rashes (lesions).

A skin lesion due to vasculitis means that you have one or more of the following:

  • Macule (a red or purple discoloration that is flat, is less than 1 cm in diameter and does not change color when pressure is applied to the discoloration),
  • Papule (a red or purple area that is raised, can be touched and is 0.3-1 cm in diameter),
  • Purpura (non-blanching red or purple discolorations measuring 0.3-1 cm in diameter),
  • Retiform purpura (a red or purple discoloration with jagged edges which does not change color when pressure is applied to it),
  • Nodule (small round lump that is more than 1 cm),

or

  • Ulcer (an open sore on the body that is caused by a break in the skin).

About this Study

At least 40 people with vasculitis will take part in this study at approximately 20 medical centers across North America. All participants will be asked to complete one visit. Some participants may be asked to return for another visit 6 months after the first visit to confirm the vasculitis diagnosis. At the first visit, you will be asked to provide information about your medical history, the current medication you are taking for your vasculitis, and you will be asked to have a photograph taken of the skin lesions you have that are related to your vasculitis. At this initial visit, you will also be asked to provide a skin biopsy sample on a skin lesion that is between 24-36 hours old or is not older than one week. If you have more than one skin lesion, you will be asked if the doctor can take two skin biopsy samples. One will be used for this study and the other will be evaluated as part of your standard care. You will also be asked to provide blood samples for research.

Target Enrollment

To be eligible to participate, you must:

  • Have a cutaneous lesion (purpuric macule or papule, retiform purpura, nodule, ulcer, 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) or microscopic polyangiitis (MPA)
    • Polyarteritis nodosa (PAN)
    • Urticarial vasculitis
  • Be willing and able to provide written informed consent (or assent for those under the age of 18)

You are not eligible to participate if:

  • You are less than five years old
  • You are considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy
  • 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

How to participate

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation.

California

  • University of California, Los Angeles, Los Angeles
    Study Coordinator: Itandewy (Tandy) Ramirez
    E-mail: ItandewyRamirez@mednet.ucla.edu
    Phone: 310-206-0994

Massachusetts

  • Boston University School of Medicine, Boston
    Study Coordinator: Christopher Zammitti
    E-mail: zammitti@bu.edu
    Phone: 617-638-5383

Minnesota

Ohio

  • Cleveland Clinic, Cleveland
    Study Coordinator: Elizabeth Kisela
    E-mail: kiselae@ccf.org
    Phone: 216-444-4887

Oregon

  • Oregon Health & Science University, Portland
    Study Coordinator: Griselda Velasco Lopez
    E-mail: velascgr@ohsu.edu
    Phone: 503-494-4770

Pennsylvania

Utah

  • University of Utah, Salt Lake City
    Study Coordinator: Lisa Webber, AEMT
    E-mail: lisa.webber@hsc.utah.edu
    Phone: 801-587-1948

Canada

Ontario

  • St. Joseph's Healthcare, Hamilton
    Sandra Messier
    Study Coordinator
    E-mail: smessier@stjoes.ca
    Phone: 905-522-1155 Ext. 33260