Adaptive immune responses to SARS-CoV-2 persist in the pharyngeal lymphoid tissue of children.
Qin Xu, Pedro Milanez-Almeida, Andrew J Martins...
https://pubmed.ncbi.nlm.nih.gov/36536106Actively Recruiting
Age: 1Month - 99Years
All Genders
ID05656365
Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-08
1500
Participants Needed
3
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) syndrome and other tonsil disorders, which are common causes of periodic fever in children. The study aims to understand how PFAPA develops by collecting genetic, immunologic, cellular, molecular, and microbial data from affected individuals. This observational study seeks to identify risk factors and immune responses related to these conditions. Participants with PFAPA or other tonsil disorders will provide various specimens, including blood, saliva, mucus, stool, and cells from the nose or mouth. Tissue samples may also be collected if participants undergo tonsil or adenoid removal surgery. Specimens can be collected either in person at study sites or remotely through local health providers. Some participants may have optional follow-up visits over a period of up to 10 years. During the study, medical records will be reviewed and family history of PFAPA will be collected. Researchers will analyze genetic variations, immune cell populations, gene and protein expression, and microbiota in tissues and samples. Outcomes include understanding immune responses, molecular pathways, and clinical effects after tonsillectomy or other treatments. The study involves specimen collection, clinical evaluations, and long-term monitoring.
CONDITIONS
Brief Title
Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders
Who Can Participate
Age: 1Month - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Participants aged 1 month or older
- Diagnosed with PFAPA or another tonsil disorder, or have symptoms consistent with these conditions
- Able to provide informed consent or have a parent/guardian provide consent
- Willing to allow specimens and data to be stored for future research
- Willing to allow genetic testing on their biospecimens
You will not qualify if you...
- Any condition that the investigator judges may put the participant at undue risk or make them unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Sample Collection
Duration - Throughout study participation
Participants provide biological specimens such as blood, saliva, swabs, washes, and stool for genetic, immunologic, cellular, molecular, and microbial research related to PFAPA and other tonsil disorders.
1 or more visits or remote sample submissions depending on participant availability
Clinical Observation
Duration - Throughout study participation
Participants who undergo routine tonsillectomy and/or adenoidectomy provide leftover clinical specimens for research and have clinical outcomes characterized following these treatments.
Visits as needed according to clinical care schedule
Long-term Monitoring
Duration - Up to several years until study completion
Participants are observed over time to characterize genetic risk variants, immune responses, microbiota, and clinical outcomes related to PFAPA and other tonsil disorders.
Periodic visits or remote follow-up as scheduled by the study team
Trial Site Locations
Total: 3 locations
1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
2
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46290
Actively Recruiting
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
M
Mary T Bowes
K
Kalpana Manthiram, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Common genetic susceptibility loci link PFAPA syndrome, Behçet's disease, and recurrent aphthous stomatitis.
Kalpana Manthiram, Silvia Preite, Fatma Dedeoglu...
https://pubmed.ncbi.nlm.nih.gov/32518111Periodic fever, aphthous stomatitis, pharyngitis, and adenitis (PFAPA) is a disorder of innate immunity and Th1 activation responsive to IL-1 blockade.
Silvia Stojanov, Sivia Lapidus, Puja Chitkara...
https://pubmed.ncbi.nlm.nih.gov/21478439