RECRUITING

A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals with Herpes Zoster.

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

The purpose of this observational research study is to study if patients with herpes zoster, also known as Shingles, have a higher risk of vascular dysfunction (problems with blood vessels, including stroke) and vascular dementia (problems with mental decline as a result of decreased blood flow to the brain) compared to patients without herpes zoster. Patients are evaluated based on the group they are assigned too: 1. Herpes Zoster (HZ) Group: individuals presenting with untreated herpes zoster. These participants will have 6 visits: * Day 1 = 1st day presenting to clinic with acute zoster * 7 days post zoster * 1 month after Day 1 * 3 months after Day 1 * 6 months after Day 1 * 12 months after Day 1 2. Control Group: individuals without herpes zoster o Day 1 (only 1 visit will be completed) This study does not have a study medication/device. Standard of care for all patients will be followed.

Official Title

Pathogenic Exosomes During Herpes Zoster Mediate Increased Vascular Dementia Risk.

Quick Facts

Study Start:2025-03
Study Completion:2030-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06903078

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be a male or female ≥ 18 years of age.
  2. 2. Present to clinic for routine dermatologic evaluation with or without rash.
  3. 3. Are willing and able to complete study visits and procedures, and able to effectively communicate with the investigator and other study personnel.
  4. 4. Have adequate venous access and are willing to undergo venipuncture for blood draws.
  5. 5. Able to provide written informed consent prior to any study procedures. Additional inclusion criteria for Herpes zoster (HZ) participants,
  6. 6. Present with acute, vesicle-stage HZ that has not been treated with antiviral therapies
  7. 7. Are willing and have reliable transportation to complete additional follow-up visits at 7 days, 1 month, 3 months, 6 months, and 12 months after initial visit for acute HZ.
  1. 1. Female individuals who are pregnant or breast-feeding.
  2. 2. Receiving systemic or topical antivirals for varicella zoster virus (VZV).
  3. 3. Sensitivity or allergy to systemic or topical antiviral medications for HZ.
  4. 4. History of diagnosed HZ within the last 8 years.
  5. 5. Received a HZ vaccine (e.g., Zostavax®/Shingrix®) within the last 8 years.
  6. 6. Received any vaccinations within the last 3 months.
  7. 7. Currently taking immunosuppressive therapies, including medications and radiation.
  8. 8. Currently taking any anticoagulants.
  9. 9. History of any coagulation disorder(s).
  10. 10. History of end-stage renal disease or uremia.
  11. 11. History of end-stage liver disease.
  12. 12. History of HIV.
  13. 13. Have had a COVID-19 infection in last 3 months.
  14. 14. Any history of non-skin cancers within the last 3 months.
  15. 15. History of serious infection requiring hospitalization in the last 3 months.
  16. 16. Prior history of cardiovascular accident or myocardial infarction within the last 12 months.
  17. 17. Prior cerebrovascular accident in the past 12 months.

Contacts and Locations

Study Contact

Study Principal Investigator
CONTACT
281-333-2288
info@ccstexas.com
Director of Research
CONTACT
281-333-2288
dyetman@ccstexas.com

Principal Investigator

Project Director
STUDY_DIRECTOR
University of Colorado, Denver

Study Locations (Sites)

Center for Clinical Studies, LTD. LLP
Houston, Texas, 77004
United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, 77598
United States

Collaborators and Investigators

Sponsor: Center for Clinical Studies, Texas

  • Project Director, STUDY_DIRECTOR, University of Colorado, Denver

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 Date2025-03
Study Completion Date2030-08

Study Record Updates

Study Start Date2025-03
Study Completion Date2030-08

Terms related to this study

Keywords Provided by Researchers

  • RO1
  • 1R01AG085406-01
  • Herpes Zoster
  • Shingles
  • Dr. Stephen Tyring
  • Dementia risk HZ
  • VZV

Additional Relevant MeSH Terms

  • Herpes Zoster (HZ)
  • Vascular Dementia