5511: Tissue Repository Collection Protocol

Status: Recruiting

The purpose of this study is to collect clinical data and biopsy tissues from patients with vasculitis. The study is being done to identify genes that increase the risk of developing vasculitis. This research team hopes that this study will develop information about vasculitis that will allow researchers to learn about the causes, the disease process and potential treatments for vasculitis.

For Diseases

  • Giant cell arteritis
  • Takayasu’s arteritis
  • Polyarteritis nodosa
  • Granulomatosis with polyangiitis (Wegener’s)
  • Microscopic polyangiitis
  • Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
  • Aortitis
  • Cutaneous vasculitis

Background

Vasculitis is the swelling or inflammation of your blood vessels. It causes your blood vessels to change by thickening, weakening, narrowing, or scarring. The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies.

The research questions aim is:

  • To establish a collection of tissue specimens from patients with various forms of vasculitis, with linked clinical data for future use in clinical and translational (findings from basic science) research projects.

About this Study

During the research study we will collect and store information from your medical records. We will ask you to sign documentation that allows the study team to request your tissue samples. You will only be seen once for this research study. In addition to collecting your leftover biopsy tissue, we will collect and store information about your disease for future genetic testing. Your DNA may be extracted from your tissue. DNA is in each cell in your body. It has the instructions used in the development and functioning of all known living organisms.

You will not undergo any additional biopsies for this research study. This study will collect biopsy tissue from your past biopsy procedures. We will also ask to receive a specimen for research purposes when a standard of care procedure is conducted in the future. Future studies may include genetic testing which could include markers, gene expression, and other genetic testing. We ask your permission to let us collect and store any clinical information related to your biopsy that has been or will be obtained by the vasculitis centers or by any of your personal doctors. This information will be stored and used by the study doctors and research team.

For research purposes only, we will collect the following:

  • Name
  • Medical record number
  • Date of birth
  • Phone number
  • Past biopsy material
  • Slides made from your prior biopsies. We plan to review these same slides, make electronic copies, and return the slides back to the hospital or center that sent them.
  • If a biopsy is completed in the future, we will collect tissue if there is anything left.
  • Clinical Data/Medical Record (which includes biopsy report and findings)
  • Medical release form (permission to collect biopsy tissue)

Target Enrollment

To be eligible to participate, you must:

  • Be/were enrolled in another one of the VCRC observational/longitudinal protocols (including but not limited to 5502, 5503, 5504, 5505, 5506, 5507, 5510, 5563) and/or one of the VCRC interventional studies (including but not limited to 5522, 5523, 5526, 5527, or 5562).

You are not eligible to participate if:

  • You (or your guardian in the case of children) are unable to give informed consent and to sign the consent form.
  • You are unwilling to allow the use of your tissue for research.

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.

United States

Massachusetts

  • Boston University School of Medicine, Boston
    Study Coordinator: Naomi Amudala, NP
    E-mail: namudala@bu.edu
    Phone: 617-358-6796

Ohio

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

Pennsylvania

  • University of Pennsylvania, Philadelphia
    Study Coordinator: Sherry Xu
    E-mail: sherryxu@pennmedicine.upenn.edu
    Phone: 215-573-2959
  • University of Pittsburgh, Pittsburgh
    Study Coordinator: Laurie Hope, RN
    E-mail: hopelk@upmc.edu
    Phone: 412-648-4098

Utah

Canada

Ontario

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