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VCRC Tissue Repository

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ClinicalTrials.gov Identifier: NCT02967068
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : March 25, 2019
Sponsor:
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

Tracking Information
First Submitted Date November 11, 2016
First Posted Date November 17, 2016
Last Update Posted Date March 25, 2019
Study Start Date November 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02967068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title VCRC Tissue Repository
Official Title VCRC Tissue Biorepository Collection Protocol
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.
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.

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
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 15, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Sherry Xu sherryxu@pennmedicine.upenn.edu
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02967068
Other Study ID Numbers VCRC5511
U54AR057319 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Peter Merkel, University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators
  • 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
PRS Account University of Pennsylvania
Verification Date March 2019