AortitisNCT02967068
VCRC Tissue Repository
An observational study of Aortitis and Cutaneous Vasculitis, run by University of Pennsylvania at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortitis, Cutaneous Vasculitis, Eosinophilic Granulomatosis With Polyangiitis
- How many people
- 1,000 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Nov 2016to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Katie Doyle contact
8 sites in 2 countries
United States6 sites, 1 recruiting
- Completed
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Completed
Boston University School of Medicine
Boston, Massachusetts, 02118
- Completed
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Katie Doyle, Kathryn.Logue@pennmedicine.upenn.edu
- Completed
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
- Completed
University of Utah
Salt Lake City, Utah, 84132
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario, L8N 3B6
Sandra Messier, smessier@stjoes.ca
- Recruiting
University of Toronto Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Nazrana Haq, Nazrana.Haq@sinaihealth.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortitis, Cutaneous Vasculitis, Eosinophilic Granulomatosis With Polyangiitis, Giant Cell Arteritis, Granulomatosis With Polyangiitis (Wegener's), Henoch-Schonlein Purpura
- Keywords
- CSS, EGPA, GCA, GPA, MPA, PAN, TAK, HSP
- Medical subject headings
- Aortitis, Skin Diseases, Vascular, Churg-Strauss Syndrome, Giant Cell Arteritis, Granulomatosis with Polyangiitis, IgA Vasculitis, Microscopic Polyangiitis, Polyarteritis Nodosa
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify genes that increase the risk of developing vasculitis
Evaluating of clinical data and linked biopsy specimens to identify genes that increase the risk of developing vasculitis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AortitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), Office of Rare Diseases (ORD)
- Responsible party
- Principal investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Peter A Merkel, MD, MPH, Study chair, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967068
- Sponsor's protocol ID
- VCRC5511
- Other IDs
- U54AR057319
- Status last verified
- Jan 2026
- First submitted
- 11 Nov 2016
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VCRC Tissue Biorepository Collection Protocol
- ClinicalTrials.gov ID
- NCT02967068
- Acronym / sponsor ID
- VCRC5511
- Conditions
- Aortitis, Cutaneous Vasculitis, Eosinophilic Granulomatosis With Polyangiitis, Giant Cell Arteritis, Granulomatosis With Polyangiitis (Wegener's), Henoch-Schonlein Purpura
- Keywords
- CSS, EGPA, GCA, GPA, MPA, PAN, TAK, HSP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), Office of Rare Diseases (ORD)
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Vasculitis Clinical Research ConsortiumLink provided by the sponsor.
- Rare Diseases Clinical Research NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katie Doyle contact
Peter A Merkel, MD, MPH study chair
University of Pennsylvania
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortitis and Cutaneous Vasculitis, run by University of Pennsylvania at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Doyle (Kathryn.Logue@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify genes that increase the risk of developing vasculitis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.