RECRUITING

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Quick Facts

Study Start:2017-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03004326

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.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis
  2. * Have a suspected or confirmed diagnosis of:
  3. * Cryoglobulinemic vasculitis (CV)
  4. * Drug-induced vasculitis
  5. * Eosinophilic granulomatosis with polyangiitis (EGPA)
  6. * IgA vasculitis
  7. * Isolated cutaneous vasculitis
  8. * Granulomatosis with polyangiitis (GPA)
  9. * Microscopic polyangiitis (MPA)
  10. * Polyarteritis nodosa (PAN)
  11. * Urticarial vasculitis
  12. * Be willing and able to provide written informed consent (or assent for those under
  1. * You are less than five years old
  2. * 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
  3. * 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
  4. * You have an uncontrolled disease that could prevent you from completing the study procedures
  5. * 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
  6. * You are pregnant or nursing
  7. * You are not able to provide informed consent

Contacts and Locations

Study Contact

Carol McAlear, MA
CONTACT
cmcalear@upenn.edu

Principal Investigator

Robert Micheletti, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Peter Grayson, MD, MSc
PRINCIPAL_INVESTIGATOR
The National Institute of Arthritis and Musculoskeletal and Skin Diseases

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States
Boston University School of Medicine
Boston, Massachusetts, 02118
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oregon Health & Science University
Portland, Oregon
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Utah
Salt Lake City, Utah
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Peter Merkel

  • Robert Micheletti, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Peter Grayson, MD, MSc, PRINCIPAL_INVESTIGATOR, The National Institute of Arthritis and Musculoskeletal and Skin Diseases

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 Registration Dates

Study Start Date2017-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2017-01
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • DIV
  • CSS
  • EGPA
  • HSP
  • GPA
  • MPA
  • PAN
  • Wegeners

Additional Relevant MeSH Terms

  • 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