NCT05584488 Allergy and Immunology Natural History Study
| NCT ID | NCT05584488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Immune Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2010-07-16 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2010-07-16 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. * Subjects must agree to have their blood stored for future studies of the immune system and/or other medical conditions. Exclusion Criteria: • The presence of an acquired abnormality of the immune system, such as cytotoxic chemotherapy or malignancy may be grounds for possible exclusion if, in the opinion of the investigator, the presence of such a disease process would interfere with evaluation.
Contact & Investigator
Joshua D. Milner, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05584488 clinical trial?
This trial is open to participants of all sexes, up to 99 Years, studying Immune Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05584488 currently recruiting?
Yes, NCT05584488 is actively recruiting participants. Contact the research team at jdm2249@cumc.columbia for enrollment information.
Where is the NCT05584488 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05584488 clinical trial?
NCT05584488 is sponsored by Columbia University. The principal investigator is Joshua D. Milner, MD at Columbia University. The trial plans to enroll 10,000 participants.