Institutional Review Board, Hospital for Special Surgery
December 13, 2013
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.
Jessica Gordon, MD
Lindsay Lally, MD
Uzunma Udeh, BA
Daniele Lerner, BA
Nina Paddu, BA
A total of 1300 patients will be enrolled in the VCRC Genetic Repository One Time DNA collection study cohort. 300 subjects with Giant Cell Arteritis, 200 subjects with Takayasu’s arteritis, 100 subjects with Polyarteritis nodosa, 500 subjects with Granulomatosis with Polyangiitis or Microscopic Polyangiitis, and 200 subjects with Churg-Strauss Syndrome. At our site, we hope to recruit 4-5 patients a year with each disease subtype.
Clinical information to be collected and stored includes the following. This information is collected as part of routine clinical practice and is not mandated by the protocol:
§ Medical history data
§ Physical examination data
§ Measures of disease activity (vasculitis disease and damage indices)
Information to be collected specifically for research purposes
§ Blood specimen for measurement of genetic markers that may increase the risk of developing vasculitis
§ Demographic data
The total volume of blood collected at the study visit is 20 ml, which is well below the limits set forth by Federal guidelines. The costs of the research blood specimens will be born by the study. Clinical data for disease assessment including signs and symptoms of vasculitis, physical examination, and demographics will be obtained at the time of the study visit. These data will be evaluated, collected, and stored as part of this study.
Inclusion Criteria A total of 1300 patients will be enrolled in the VCRC Genetic Repository One Time DNA collection study cohort. 300 subjects with Giant Cell Arteritis, 200 subjects with Takayasu’s arteritis, 100 subjects with Polyarteritis nodosa, 500 subjects with Granulomatosis with Polyangiitis or Microscopic Polyangiitis, and 200 subjects with Churg-Strauss Syndrome. Enrollment will be sequential and patients will have disease in various stages and of different duration.
Exclusion Criteria General exclusion criteria include inability to give informed consent and to sign the consent form, enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523, or unwilling to provide blood for DNA collection.