Allergy and Immunology Natural History Study
Natural History Study for Genetic Diseases of Allergic Inflammation and Immune Dysregulation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- Up to 99 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at genes and how the immune system works in people with known or suspected inherited diseases that cause allergies or immune system problems. It includes patients and some family members, using body samples, medical records, and possible health exams to better understand these diseases.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are from birth to age 99 and have, or may have, an inherited condition that affects allergic swelling, allergy cells called mast cells, or how the immune system works.
- Blood relatives of people enrolled in the study may also join.
- People may join regardless of gender, race, or disability.
- You or your guardian must be willing and able to give informed consent, which means agreeing after learning about the study.
- You must agree to have your blood stored for future studies of the immune system or other health conditions.
Who can't join
- You may not be able to join if you have an immune system problem that is not inherited, such as one related to cancer or chemotherapy. The study doctor will decide whether it would interfere with the study evaluation.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
NY
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital · New York, NY 10032Yannett Franklin · Study contact · 212-305-0473 · ym206@cumc.columbia.eduAlexis Boneparth, MD · Sub-investigatorManar Abdalgani, MBBS · Sub-investigatorEmily Mace, PhD · Sub-investigatorMore trials in New York