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NCT04798079 · ClinicalTrials.gov registry record
Systems Biology of Early Atopy
A clinical trial of Atopic Dermatitis and Food Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- 2,500
- Enrollment target
- 13
- Study locations
NCT04798079: Active study of Atopic Dermatitis and Food Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04798079 is a study of Atopic Dermatitis and Food Allergy that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2,500 participants, above the 593-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (322% higher). The trial reports 13 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04798079, a study of Atopic Dermatitis and Food Allergy, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- 2,500 participants
- Enrollment target
- 13
- Study locations
Study Summary
The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: * To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development and course of allergic diseases through age 3 years (or 6 years for those who choose to continue participation into SUNBEAM II), with an emphasis on atopic dermatitis and food allergy * To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes * To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development
Primary Outcome
To understand the early life origin and risk factors of child's IgE-mediated, immediate-type food allergy. Based upon clinical assessments and diagnostic criteria for food allergy, in accordance with the Food Allergy Algorithm, per protocol.
Conditions Studied
Study Locations (13)
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- Sean N. Parker Center for Allergy & Asthma Research at Stanford University - Stanford
Colorado
- National Jewish Health - Denver
Illinois
- Northwestern University Feinberg School of Medicine: Dept of Dermatology - Chicago
Maryland
- Johns Hopkins Children's Center, Department of Allergy & Immunology - Baltimore
Massachusetts
- Massachusetts General Hospital, Translational and Clinical Research Center - Boston
Michigan
- Henry Ford Health System, Division of Allergy and Immunology - Detroit
New York
- Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2021-03-18 |
| Est. Completion | 2032-03 |
What the registry record for NCT04798079 still lists
NCT04798079 is an observational study that tracks outcomes without assigning an intervention. Its 2,500 participants enrollment target places it among the larger protocols in the corpus, above the 593-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (322% higher).
The record links to 3 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 0 interventions.
NCT04798079 lists 13 locations in 13 states (Arkansas, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT04798079 about?
NCT04798079 is a clinical study titled "Systems Biology of Early Atopy". The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as w...
What is the current status of trial NCT04798079?
This trial is currently active not recruiting. The enrollment target is 2,500 participants. The study started on 2021-03-18. Estimated completion is 2032-03.
What conditions does trial NCT04798079 study?
This clinical trial studies the following conditions: Atopic Dermatitis, Food Allergy, Allergic Diseases.
Who is sponsoring clinical trial NCT04798079?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04798079 being conducted?
This trial has 13 study locations across Arkansas, California, Colorado, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04798079's enrollment target sits among peer trials
2,500 7th of 150 higher than 144 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
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