VCRC Tissue Repository

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT02967068
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), National Center for Advancing Translational Science (NCATS) (NIH), Office of Rare Diseases (ORD) (NIH)
1,000
8
70
125
1.8

Study Details

Study Description

Brief Summary

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.

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
VCRC Tissue Biorepository Collection Protocol
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Identify genes that increase the risk of developing vasculitis [1 year]

    Evaluating of clinical data and linked biopsy specimens to identify genes that increase the risk of developing vasculitis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115
2 Boston University School of Medicine Boston Massachusetts United States 02118
3 Cleveland Clinic Cleveland Ohio United States 44195
4 University of Pennsylvania Philadelphia Pennsylvania United States 19104
5 University of Pittsburgh Pittsburgh Pennsylvania United States 15261
6 University of Utah Salt Lake City Utah United States 84132
7 St. Joseph's Healthcare Hamilton Ontario Canada L8N 3B6
8 University of Toronto Mount Sinai Hospital Toronto Ontario Canada M5G 1X5

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Peter Merkel, Chief, Division of Rheumatology Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02967068
Other Study ID Numbers:
  • VCRC5511
  • U54AR057319
First Posted:
Nov 17, 2016
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Peter Merkel, Chief, Division of Rheumatology Professor of Medicine and Epidemiology, University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022