Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Study Purpose

Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 5 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis - Have a suspected or confirmed diagnosis of: - Cryoglobulinemic vasculitis (CV) - Drug-induced vasculitis - Eosinophilic granulomatosis with polyangiitis (EGPA) - IgA vasculitis - Isolated cutaneous vasculitis - Granulomatosis with polyangiitis (GPA) - Microscopic polyangiitis (MPA) - Polyarteritis nodosa (PAN) - Urticarial vasculitis - Be willing and able to provide written informed consent (or assent for those under

Exclusion Criteria:

- You are less than five years old - Considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for you participating in this study do not outweigh the potential benefit of learning information from your biopsy - You have a neutrophil count (type of white blood cell) less than 1500/mm3, platelet count less than 50,000/mm3, or a hemoglobin less than 7 g/dL - You have an uncontrolled disease that could prevent you from completing the study procedures - You have an active infection at or near the potential biopsy site, have poor circulation, or have bony prominence or other structure that would increase your risk of complications if you participated in this study - You are pregnant or nursing - You are not able to provide informed consent

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03004326

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Peter Merkel

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Robert Micheletti, MDPeter Grayson, MD, MSc
Principal Investigator Affiliation University of PennsylvaniaThe National Institute of Arthritis and Musculoskeletal and Skin Diseases

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherNIHNIHOther
Overall Status Recruiting
Countries Canada, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), IgA Vasculitis, Isolated Cutaneous Vasculitis, Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA), Polyarteritis Nodosa (PAN), Urticarial Vasculitis, Vasculitis
Study Website: View Trial Website
Additional Details

This study employs a multi-center approach to evaluate cutaneous vasculitis across several forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be evaluated by teams of primary vasculitis care providers and Dermatologists in order to facilitate optimal selection of patients and sampling of lesions. A punch skin biopsy at a site of active vasculitis will be the source of material for histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis will be characterized using a standardized approach.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah,

Site Contact

Lisa Webber

lisa.webber@hsc.utah.edu

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Michelle Hampton

michelle.hampton@uphs.upenn.edu

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon,

Site Contact

Anna Ward

waran@ohsu.edu

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Katrina Pierce

pierce.katrina@mayo.edu

Boston University School of Medicine, Boston, Massachusetts

Status

Recruiting

Address

Boston University School of Medicine

Boston, Massachusetts, 02118

Site Contact

Chris Zammitti

zammitti@bu.edu

University of California, Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California, Los Angeles

Los Angeles, California, 90095

Site Contact

Tandy Ramirez

ItandewyRamirez@mednet.ucla.edu

International Sites

Toronto, Ontario, Canada

Status

Recruiting

Address

University of Toronto Mount Sinai Hospital

Toronto, Ontario, M5G 1X5

Site Contact

Judy Vendramini

judy.vendramini@sinaihealthsystem.ca

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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