RECRUITING

Coagulopathy of Immunodermatologic Diseases

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Conditions

Autoimmune Bullous Dermatosis

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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

This study will examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. Blood samples will be collected from participants with active/poorly controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin diseases. A one-time sample from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy will also be collected to serve as control. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.

Official Title

Coagulopathy of Immunodermatologic Diseases The Molecular, Prognostic, and Therapeutic Implications of Crosstalk Between Coagulation, Fibrinolysis, and Inflammation in Immune-Mediated Skin Diseases

Quick Facts

Study Start:2023-05-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06037187

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:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. For the study group: diagnosis of immune-mediated skin disease including but not limited to bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus, dermatomyositis
  2. 2. For control group: no diagnosis of immune-mediated skin
  3. 3. For study group: receiving care from one or more of the Principal or Secondary Investigators
  1. 1. Unfit to provide consent
  2. 2. P2Y12 inhibitor use in the past 4 weeks
  3. 3. History of internal malignancy prior to enrolling in the study or suspected internal/systemic malignancy during time of the study (i.e. will not exclude pre-malignant or local, early stage cutaneous malignancies)
  4. 4. Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone fracture) within 4 weeks of the study
  5. 5. Other autoimmune diseases not in remission defined as flare in the last 12 weeks
  6. 6. If patient is unable to provide detailed history and if we do not have sufficient history on record.
  7. 7. Less than 19 years of age

Contacts and Locations

Study Contact

Megan E Wackel, MS
CONTACT
402-559-3825
megan.wackel@unmc.edu

Principal Investigator

Erin X Barrett, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Erin X Barrett, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

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 Date2023-05-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-05-09
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Autoimmune Bullous Dermatosis