VCRC Tissue Repository

January 23, 2024 updated by: Peter Merkel, University of Pennsylvania

VCRC Tissue Biorepository Collection Protocol

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3B6
      • Toronto, Ontario, Canada, M5G 1X5
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Completed
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Completed
        • Boston University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15261
        • Completed
        • University of Pittsburgh
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Completed
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Sciences (NCATS)
Office of Rare Diseases (ORD)

Investigators

  • Study Chair: Peter A Merkel, MD, MPH, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 11, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimated)

November 17, 2016

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCRC5511
  • U54AR057319 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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