Research

VCRC Genetic Repository One Time DNA Protocol

IRB Number: 2014-278

Institutional Review Board, Hospital for Special Surgery

October 06, 2016

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Robert F. Spiera, MD

Co-Investigators

Lindsay S. Lally, MD
Jessica K. Gordon, MD
Annel Fernandez
Emily Bakaj
Alexandra Morquette

Summary

The purpose of this registry is to identify factors that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels.  Results of this study will provide vasculitis researchers insight into the causes of these diseases and generate new ideas of diagnostic test and therapies. Currently, we have 27 patients enrolled. Participation in this study involves a single 45 minute visit where clinical data will be collected as well as a blood draw.

Inclusion/Exclusion Criteria

Inclusion criteria:

  • Patients must be able to provide informed consent
  • Patients must meet diagnostic criteria for at least one of the following vasculitis-related diseases:
    • Giant Cell Arteritis
    • Takayasu's Arteritis
    • Polyarteritis Nodosa
    • Granulomatosis with Wegener’s and Microscopic Polyangiitis
    • Churg-Strauss Syndrome

Exclusion criteria:

  • Inability to give informed consent and to sign the consent form
  • Enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523
  • Unwilling to provide blood for DNA collection