Natural history study of allergic inflammation and immune disorders
Natural History Study for Genetic Diseases of Allergic Inflammation and Immune Dysregulation
Columbia University · NCT05584488
This study is looking at people with genetic allergies and immune issues to see how their bodies work and improve how we diagnose and treat these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | N/A to 99 Years |
| Sex | All |
| Sponsor | Columbia University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05584488 on ClinicalTrials.gov |
What this trial studies
This study evaluates individuals with suspected or identified genetic diseases related to allergic inflammation and immune dysregulation. Participants, including their family members, will provide various biological samples such as blood, saliva, and tissue biopsies for research aimed at understanding the genetic and immunological underpinnings of these conditions. The study seeks to correlate clinical evaluations with laboratory findings to enhance the diagnosis and management of atopic diseases and immune disorders. By investigating both known and novel disorders, the research aims to uncover critical insights into the mechanisms of allergic inflammation.
Who should consider this trial
Good fit: Ideal candidates include individuals of any age with suspected or confirmed inherited disorders of allergic inflammation or immune dysregulation.
Not a fit: Patients with acquired immune system abnormalities, such as those undergoing chemotherapy or with malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and management strategies for patients with allergic and immune disorders.
How similar studies have performed: Other studies focusing on genetic and immunological aspects of allergic diseases have shown promise, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Joshua D. Milner, MD — Columbia University
- Study coordinator: Joshua D. Milner, MD
- Email: jdm2249@cumc.columbia
- Phone: 212-305-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immune Deficiency, Immune Dysregulation Disorder, Allergic Inflammation, Eosinophilic Disease, Anaphylaxis, Elevated IgE levels, Autoimmune diseases, Allergy