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VCRC Tissue Repository

This study is currently recruiting participants.
Verified October 2017 by Peter Merkel, University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT02967068
First Posted: November 17, 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 (ORD)
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania
  Purpose
The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens and linked clinical data collected through VCRC studies may lead to the identification and development of a series of translational research projects. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.

Condition
Aortitis Cutaneous Vasculitis Eosinophilic Granulomatosis With Polyangiitis Giant Cell Arteritis Granulomatosis With Polyangiitis (Wegener's) Henoch-Schonlein Purpura IgA Vasculitis Microscopic Polyangiitis Polyarteritis Nodosa Takayasu Arteritis Churg-Strauss Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: VCRC Tissue Biorepository Collection Protocol

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Identify genes that increase the risk of developing vasculitis [ Time Frame: 1 year ]
    Evaluating of clinical data and linked biopsy specimens to identify genes that increase the risk of developing vasculitis.


Biospecimen Retention:   Samples With DNA
Biopsy specimens collected as standard of care for these diseases will be retrieved and used in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels.

Estimated Enrollment: 1000
Study Start Date: November 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Detailed Description:
Biopsy specimens collected as standard of care for these diseases will be retrieved and used in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels; however, other tissue is also of interest for the study. Biopsies are not performed as part of this protocol, rather we will request consent to collect biopsy specimens already collected under routine care.
  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:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 1000 patients with GCA, TAK, PAN, GPA, MPA, EGPA, cutaneous vasculitis and aortitis will potentially be enrolled into the VCRC Tissue Biorepository Collection Protocol.

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

Biopsies are not performed as part of this protocol, rather we will request consent to collect biopsy specimens already collected under routine care.

Criteria

Inclusion Criteria:

  • A participant will be deemed eligible for this study if the participant is/was enrolled in another one of the VCRC observational/longitudinal protocols (5502, 5503, 5504, 5505, 5506, 5507, 5563) and/or one of the VCRC interventional studies (5522, 5523, 5526, 5527, or 5562).

Exclusion Criteria:

  • Inability to give informed consent (or their guardians in the case of children) and to sign the consent form.
  • Unwilling to allow the use of their tissue for research.
  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): NCT02967068


Contacts
Contact: Marina Fanous marina.fanous@uphs.upenn.edu

Locations
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Naomi Amudala       namudala@bu.edu   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Elizabeth Kisela       kiselae@ccf.org   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marina Fanous       marina.fanous@uphs.upenn.edu   
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Laurie Hope       hopelk@upmc.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jessica Gonzalez       jessica.gonzalez@hsc.utah.edu   
Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 3B6
Contact: Sandra Messier       smessier@stjoes.ca   
Sponsors and Collaborators
University of Pennsylvania
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Science (NCATS)
Office of Rare Diseases (ORD)
Investigators
Study Chair: Peter A Merkel, MD, MPH University of Pennsylvania
  More Information

Additional Information:
Responsible Party: Peter Merkel, Chief, Division of Rheumatology Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02967068     History of Changes
Other Study ID Numbers: VCRC5511
U54AR057319 ( U.S. NIH Grant/Contract )
First Submitted: November 11, 2016
First Posted: November 17, 2016
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Vasculitis
Systemic Vasculitis
Vasculitis, Central Nervous System
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Purpura
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Takayasu Arteritis
Aortic Arch Syndromes
Churg-Strauss Syndrome
Purpura, Schoenlein-Henoch
Polyarteritis Nodosa
Aortitis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular