Clinical trial NCT06605378: Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease
Official title: A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Granulomatous Disease (CGD)
Keywords: CGD
X-CGD
Chronic Granulomatous Disease
Granulomatous Disease, Chronic
Autosomal Recessive Chronic Granulomatous Disease
Lead sponsor: Ensoma
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with CGD

Brief summary: This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total adenoviral-specific antibody (TAb) titer
timeFrame: 1 Day
measure: Adenoviral-specific neutralizing antibody (NAb) titer
timeFrame: 1 Day
Secondary outcomes:
measure: Circulating inflammatory cytokine levels
timeFrame: 1 Day
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Home-based telemedicine
state: Alabama
city: Phoenix
country: United States
facility: Home-based telemedicine
state: Arizona
city: Little Rock
country: United States
facility: Home-based telemedicine
state: Arkansas
city: Sacramento
country: United States
facility: Home-based telemedicine
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Home-based telemedicine
state: Colorado
city: Hartford
country: United States
facility: Home-based telemedicine
state: Connecticut
city: Dover
country: United States
facility: Home-based telemedicine
state: Delaware
city: Washington
country: United States
facility: Home-based telemedicine
state: District of Columbia
city: Tallahassee
country: United States
facility: Home-based telemedicine
state: Florida
city: Atlanta
country: United States
facility: Home-based telemedicine
state: Georgia
city: Boise
country: United States
facility: Home-based telemedicine
state: Idaho
city: Springfield
country: United States
facility: Home-based telemedicine
state: Illinois
city: Indianapolis
country: United States
facility: Home-based telemedicine
state: Indiana
city: Des Moines
country: United States
facility: Home-based telemedicine
state: Iowa
city: Topeka
country: United States
facility: Home-based telemedicine
state: Kansas
city: Frankfort
country: United States
facility: Home-based telemedicine
state: Kentucky
city: Baton Rouge
country: United States
facility: Home-based telemedicine
state: Louisiana
city: Augusta
country: United States
facility: Home-based telemedicine
state: Maine
city: Annapolis
country: United States
facility: Home-based telemedicine
state: Maryland
city: Boston
country: United States
facility: Home-based telemedicine
state: Massachusetts
city: Lansing
country: United States
facility: Home-based telemedicine
state: Michigan
city: St. Paul
country: United States
facility: Home-based telemedicine
state: Minnesota
city: Jackson
country: United States
facility: Home-based telemedicine
state: Mississippi
city: Jefferson City
country: United States
facility: Home-based telemedicine
state: Missouri
city: Helena
country: United States
facility: Home-based telemedicine
state: Montana
city: Lincoln
country: United States
facility: Home-based telemedicine
state: Nebraska
city: Carson City
country: United States
facility: Home-based telemedicine
state: Nevada
city: Concord
country: United States
facility: Home-based telemedicine
state: New Hampshire
city: Trenton
country: United States
facility: Home-based telemedicine
state: New Jersey
city: Santa Fe
country: United States
facility: Home-based telemedicine
state: New Mexico
city: Albany
country: United States
facility: Home-based telemedicine
state: New York
city: Morrisville
country: United States
facility: Science 37, Inc
state: North Carolina
city: Bismarck
country: United States
facility: Home-based telemedicine
state: North Dakota
city: Columbus
country: United States
facility: Home-based telemedicine
state: Ohio
city: Oklahoma City
country: United States
facility: Home-based telemedicine
state: Oklahoma
city: Salem
country: United States
facility: Home-based telemedicine
state: Oregon
city: Harrisburg
country: United States
facility: Home-based telemedicine
state: Pennsylvania
city: Providence
country: United States
facility: Home-based telemedicine
state: Rhode Island
city: Columbia
country: United States
facility: Home-based telemedicine
state: South Carolina
city: Pierre
country: United States
facility: Home-based telemedicine
state: South Dakota
city: Nashville
country: United States
facility: Home-based telemedicine
state: Tennessee
city: Austin
country: United States
facility: Home-based telemedicine
state: Texas
city: Salt Lake City
country: United States
facility: Home-based telemedicine
state: Utah
city: Montpelier
country: United States
facility: Home-based telemedicine
state: Vermont
city: Richmond
country: United States
facility: Home-based telemedicine
state: Virginia
city: Olympia
country: United States
facility: Home-based telemedicine
state: Washington
city: Charleston
country: United States
facility: Home-based telemedicine
state: West Virginia
city: Madison
country: United States
facility: Home-based telemedicine
state: Wisconsin
city: Cheyenne
country: United States
facility: Home-based telemedicine
state: Wyoming
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
Study officials:
References: