A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease
| Registry | NCT06605378 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 60 (Estimated) |
| Sponsor | Ensoma (Industry) |
| Conditions | Chronic Granulomatous Disease (CGD) |
| Dates | start 2024-11-18, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-09-20, last updated 2026-08-17 |
| Locations | 52 sites in United States, United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Granulomatous Disease (CGD)
This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.
In this observational study, blood samples will be collected from adult and pediatric patients with CGD. The level of circulating adenovirus antibodies and inflammatory cytokines will be measured to characterize the prevalence of these markers in this population.
Sex: All
Inclusion Criteria: * The participant must have been diagnosed with CGD based on the referring physician's confirmation that NADPH oxidase activity is ≤5% (i.e., the percentage of dihydrorhodamine-positive \[DHR+\] cells is ≤5% by flow cytometry) OR based on confirmed pathogenic mutation in a CGD associated gene (CYBB, CYBA, NCF1, NCF2, NCF4, or CYBC1). * The participant or the participant's legally authorized guardian or representative (if applicable) must be capable of giving signed informed consent. * The participant (with assistance from the participant's legally authorized guardian/representative or primary caregiver, if applicable) must be capable of complying with the requirements and restrictions listed in the protocol and informed consent form (ICF). Exclusion Criteria: * The participant has undergone an allogeneic bone marrow transplant or investigational gene therapy. * The participant is unable to comply with the sample collection procedure based on investigator judgment.
| Facility | City | Country | Status |
|---|---|---|---|
| Home-based telemedicine | Montgomery, Alabama | United States | Recruiting |
| Home-based telemedicine | Phoenix, Arizona | United States | Recruiting |
| Home-based telemedicine | Little Rock, Arkansas | United States | Recruiting |
| Home-based telemedicine | Sacramento, California | United States | Recruiting |
| University of California, San Francisco | San Francisco, California | United States | Recruiting |
| Home-based telemedicine | Denver, Colorado | United States | Recruiting |
| Home-based telemedicine | Hartford, Connecticut | United States | Recruiting |
| Home-based telemedicine | Dover, Delaware | United States | Recruiting |
| Home-based telemedicine | Washington D.C., District of Columbia | United States | Recruiting |
| Home-based telemedicine | Tallahassee, Florida | United States | Recruiting |
| Home-based telemedicine | Atlanta, Georgia | United States | Recruiting |
| Home-based telemedicine | Boise, Idaho | United States | Recruiting |
| Home-based telemedicine | Springfield, Illinois | United States | Recruiting |
| Home-based telemedicine | Indianapolis, Indiana | United States | Recruiting |
| Home-based telemedicine | Des Moines, Iowa | United States | Recruiting |
| Home-based telemedicine | Topeka, Kansas | United States | Recruiting |
| Home-based telemedicine | Frankfort, Kentucky | United States | Recruiting |
| Home-based telemedicine | Baton Rouge, Louisiana | United States | Recruiting |
| Home-based telemedicine | Augusta, Maine | United States | Recruiting |
| Home-based telemedicine | Annapolis, Maryland | United States | Recruiting |
| Home-based telemedicine | Boston, Massachusetts | United States | Recruiting |
| Home-based telemedicine | Lansing, Michigan | United States | Recruiting |
| Home-based telemedicine | Saint Paul, Minnesota | United States | Recruiting |
| Home-based telemedicine | Jackson, Mississippi | United States | Recruiting |
| Home-based telemedicine | Jefferson City, Missouri | United States | Recruiting |
| Home-based telemedicine | Helena, Montana | United States | Recruiting |
| Home-based telemedicine | Lincoln, Nebraska | United States | Recruiting |
| Home-based telemedicine | Carson City, Nevada | United States | Recruiting |
| Home-based telemedicine | Concord, New Hampshire | United States | Recruiting |
| Home-based telemedicine | Trenton, New Jersey | United States | Recruiting |
| Home-based telemedicine | Santa Fe, New Mexico | United States | Recruiting |
| Home-based telemedicine | Albany, New York | United States | Recruiting |
| Science 37, Inc | Morrisville, North Carolina | United States | Recruiting |
| Home-based telemedicine | Bismarck, North Dakota | United States | Recruiting |
| Home-based telemedicine | Columbus, Ohio | United States | Recruiting |
| Home-based telemedicine | Oklahoma City, Oklahoma | United States | Recruiting |
| Home-based telemedicine | Salem, Oregon | United States | Recruiting |
| Home-based telemedicine | Harrisburg, Pennsylvania | United States | Recruiting |
| Home-based telemedicine | Providence, Rhode Island | United States | Recruiting |
| Home-based telemedicine | Columbia, South Carolina | United States | Recruiting |
| Home-based telemedicine | Pierre, South Dakota | United States | Recruiting |
| Home-based telemedicine | Nashville, Tennessee | United States | Recruiting |
| Home-based telemedicine | Austin, Texas | United States | Recruiting |
| Home-based telemedicine | Salt Lake City, Utah | United States | Recruiting |
| Home-based telemedicine | Montpelier, Vermont | United States | Recruiting |
| Home-based telemedicine | Richmond, Virginia | United States | Recruiting |
| Home-based telemedicine | Olympia, Washington | United States | Recruiting |
| Home-based telemedicine | Charleston, West Virginia | United States | Recruiting |
| Home-based telemedicine | Madison, Wisconsin | United States | Recruiting |
| Home-based telemedicine | Cheyenne, Wyoming | United States | Recruiting |
| Great Ormond Street Hospital for Children | London | United Kingdom | Completed |
| Royal Free London NHS Foundation Trust | London | United Kingdom | Completed |