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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-100
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study.

Individuals who have a history of keloid formation

Children (<18 years old)

Participants who are pregnant

Trial population

Participants aged 3 and older with suspected or diagnosed allergic diseases of varying types will be enrolled. Participants will be generally healthy, community-dwelling participants without severe medical needs requiring hospitalization.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 3 trial groups
Group A: Conditions that may be initially evaluated or managed by A&amp;I but not categorized in 1 or 2 above
Group B: Individuals with a suspected allergic or atopic disease
Group C: Individuals with an allergic, atopic, or sinus disease

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.