Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Granulomatous Disease (CGD). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease
Overview
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.
Primary outcome measures
- Total adenoviral-specific antibody (TAb) titer [Time frame: 1 Day]
- Adenoviral-specific neutralizing antibody (NAb) titer [Time frame: 1 Day]
Secondary outcome measures (1)
- Circulating inflammatory cytokine levels [Time frame: 1 Day]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 50 centers
- Home-based telemedicine — Montgomery
- Home-based telemedicine — Phoenix
- Home-based telemedicine — Little Rock
- Home-based telemedicine — Sacramento
- University of California, San Francisco — San Francisco
- Home-based telemedicine — Denver
- Home-based telemedicine — Hartford
- Home-based telemedicine — Dover
- … and 42 more centers
United Kingdom · 2 centers
- Great Ormond Street Hospital for Children — London
- Royal Free London NHS Foundation Trust — London
Identifiers
NCT: NCT06605378 · EN-374-100