Allergy and Immunology Natural History Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 99
SponsorColumbia University
About this trial
This protocol is a natural history study designed to evaluate subjects (and some family members) with suspected or identified genetic diseases of allergic inflammation or Immune Dysregulation. Patients determined by clinical history and outside evaluations to be of interest will be consented and enrolled into this study. Blood specimens, stored blood products and derivatives, saliva, hair, fingernail clippings, cord blood, umbilical cord, bone marrow, tissue biopsies and/or buccal swabs from such patients and/or their family members will be obtained for research studies related to understanding genetic and immunopathogenic bases of these diseases. Outside medical records may be obtained, and patient evaluations may be performed to correlate to research laboratory testing results.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects, ages birth to 99 years old, known to have or suspected of having an inherited disorder of allergic inflammation, or mast cell homeostasis, or activation or immune dysregulation.
Blood relatives of enrolled subjects will be eligible for enrollment.
There will be no discrimination as to age, gender, race, or disability.
Subjects/guardians must be willing and able to give informed consent.
Disqualifiers
None
Trial population
The total study population for this protocol is up to 10,000 subjects. It is estimated that one half of the total study population will consist of subjects, with the remaining half being biological relatives. Subjects and relatives may be enrolled.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Inherited diseases of allergic inflammation or immune dysregulation
Trial outcomes
Primary outcomes
1
Total number of underlying susceptibility trait(s) identified
The primary endpoint will be the determination of the underlying susceptibility trait(s).
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov