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Search / Trial NCT03004326

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Launched by PETER MERKEL · Dec 22, 2016

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Div Css Egpa Hsp Gpa Mpa Pan Wegeners

ClinConnect Summary

The CUTIS trial is a research study aimed at understanding certain skin conditions caused by a group of diseases known as vasculitis. Vasculitis occurs when blood vessels become inflamed, and this study specifically looks at skin lesions in patients with different types of this condition, such as Cryoglobulinemic Vasculitis and Eosinophilic Granulomatosis With Polyangiitis. By examining the tissue and genetic material from these skin lesions, researchers hope to learn more about how these diseases work, which could lead to better treatments in the future.

To be eligible for the study, participants need to be 18 years or older and have a specific type of skin lesion that doctors believe is linked to active vasculitis. They should also have a suspected or confirmed diagnosis of one of the listed types of vasculitis. Participants will need to agree to undergo a skin biopsy, which is a procedure where a small sample of skin is taken for analysis. Those who are pregnant, have certain health issues, or cannot provide consent may not be able to participate. Overall, this trial is a chance for individuals with these conditions to contribute to important medical research that could improve understanding and treatment of vasculitis.

Gender

ALL

Eligibility 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

About Peter Merkel

Peter Merkel is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a robust background in rheumatology and a focus on rare diseases, Dr. Merkel leads innovative clinical trials that explore novel therapeutic interventions. His work is characterized by a strong dedication to scientific rigor, ethical standards, and collaboration with multidisciplinary teams. By fostering partnerships with academic institutions and industry stakeholders, Peter Merkel aims to translate groundbreaking research into effective treatments, ultimately enhancing the quality of care for patients with complex health conditions.

Locations

Rochester, Minnesota, United States

Philadelphia, Pennsylvania, United States

Los Angeles, California, United States

Boston, Massachusetts, United States

Charlottesville, Virginia, United States

Cleveland, Ohio, United States

Portland, Oregon, United States

Salt Lake City, Utah, United States

Rochester, Minnesota, United States

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Robert Micheletti, MD

Principal Investigator

University of Pennsylvania

Peter Grayson, MD, MSc

Principal Investigator

The National Institute of Arthritis and Musculoskeletal and Skin Diseases

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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