50 Participants Needed

Clinical Transcriptomics for Vasculitis

(CUTIS Trial)

Recruiting at 2 trial locations
CM
Overseen ByCarol McAlear, MA
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Peter Merkel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding skin changes in individuals with various types of vasculitis, a condition characterized by inflamed blood vessels. Researchers aim to study skin lesions, such as purplish spots or nodules, to gain insights into how these conditions affect the body at a cellular level. As an observational study, no treatment will be administered; researchers will only collect information. Candidates may be suitable if they have a skin lesion that a doctor suspects is related to vasculitis and have one of several specific types, such as IgA vasculitis or drug-induced vasculitis. As an unphased trial, this study provides a unique opportunity to contribute to scientific understanding without undergoing treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the CUTIS trial because it uses clinical transcriptomics to explore systemic vasculitis in a completely new way. Unlike traditional treatments that focus on managing symptoms with medications like corticosteroids or immunosuppressants, this approach aims to understand the disease at the genetic level. By analyzing gene expression in patients, scientists hope to uncover specific biomarkers and pathways that could lead to more targeted and effective therapies. This could revolutionize how we diagnose and treat systemic vasculitis, potentially leading to personalized treatment plans tailored to each patient's unique genetic makeup.

Who Is on the Research Team?

RM

Robert Micheletti, MD

Principal Investigator

University of Pennsylvania

PG

Peter Grayson, MD, MSc

Principal Investigator

The National Institute of Arthritis and Musculoskeletal and Skin Diseases

Are You a Good Fit for This Trial?

Inclusion Criteria

Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis
Cryoglobulinemic vasculitis (CV)
Drug-induced vasculitis
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Patients with cutaneous manifestations of vasculitis are evaluated by primary vasculitis care providers and Dermatologists for optimal selection and sampling of lesions.

Ongoing throughout the study

Biopsy and Analysis

A punch skin biopsy at a site of active vasculitis is performed for histopathologic and transcriptomic evaluation.

1 year

Follow-up

Participants are monitored for safety and effectiveness after biopsy and analysis.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Observational Study

Find a Clinic Near You

Who Is Running the Clinical Trial?

Peter Merkel

Lead Sponsor

Trials
2
Recruited
80+

Office of Rare Diseases Research (ORDR)

Collaborator

Trials
1
Recruited
50+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+