A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06732414
Status
Recruiting

Conditions

  • Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

Eligibility Criteria

Sex
ALL
Age
3 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

Background: Allergic or sinus diseases can affect the skin, sinuses, airways, and other parts of the body. Examples include pollen and environmental allergies, food allergies, asthma, and eczema. To learn more about how to prevent and treat these diseases, researchers need to study data, blood, fluid, and tissue samples from people affected by them. Objective: To collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases. Eligibility: People aged 3 to 100 years with allergic or sinus diseases. Design: Participants will have at least one clinic visit, and most participants will have a baseline visit, annual visit, and an end of study visit. The duration of the study is 1 to 3 years. During the first clinic visit, the following procedures will be done to collect data, blood, fluid, and tissue samples: * Blood will be collected. * Cells and fluid may be collected from the inside of the nose using a long swab, and a small piece of skin may be scraped from inside the nose. * Skin cells will be collected by rubbing with a cotton swab. * A urine sample will be collected. * Allergy skin prick tests. Allergy-causing substances will be placed on the back or arm and the skin underneath gently scratched. If the participant is allergic to the substance, the skin may become red, itchy, and swollen locally ( at the site of the test). * Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs. * If, as part of their routine care, participants are undergoing procedures such as having nasal polyps removed, skin tissue samples taken, or gastrointestinal biopsies, additional tissues may be collected for this study. * Participants will complete online questionnaires regarding their symptoms, health, and life. Participants may return for more visits for up to 3 years.

Key Dates

Start date
Jan 28, 2025
Status verified
Nov 2025
Primary completion
Nov 1, 2044
Completion
Nov 1, 2045

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Conditions that may be initially evaluated or managed by A&I but not categorized in 1 or 2 above
    Conditions that may be initially evaluated or managed by an allergist-immunologist or rhinologist but not categorized in (1) or (2) above (eg, hypereosinophilia, mast cell disorders, pruritus, chronic cough, smell disorders)
  • Arm: Individuals with a suspected allergic or atopic disease
    Individuals with a suspected allergic or atopic disease, but without demonstrated allergen sensitization (eg, contact hypersensitivity, chronic spontaneous urticaria, drug allergy)
  • Arm: Individuals with an allergic, atopic, or sinus disease
    Individuals with an allergic, atopic, or sinus disease (eg, atopic dermatitis, eosinophilic esophagitis (EoE), asthma, chronic rhinosinusitis with polyposis) with documented allergen sensitization in the skin or blood

Primary Outcome Measure

Create a repository of clinical, laboratory, and diagnostic data and specimens from a cohort of suspected or confirmed atopic or allergic individuals with diverse disorders seen by allergist-immunologists and rhinologists. [ Time Frame: 20 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
800-411-1222
Hye Jeong Bolan, M.S.N.
(301) 594-1233

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