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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
3 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not 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

  • Visits mentioned: 1 visit
  • Time periods mentioned: 3 years
  • Procedures mentioned: Phone or video check-ins, Biopsies, Questionnaires

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
  • "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."
  • "Participants may return for more visits for up to 3 years."
  • "Study Description: This is a single-site repository study that will prospectively collect samples and data from participants with allergic and atopic diseases and associated conditions such as chronic rhinosinusitis and nasal polyposis, through the evaluation, testing, and monitoring of patients with these conditions at the NIH Clinical Center (CC) and via telehealth visits and/or send-in samples."
  • "Additionally, extra skin, nasal sinus polyp, and gastrointestinal biopsies may be collected during clinically indicated procedures."
  • "The following assessments will also be performed for research purposes: Data collected from patient reported outcomes (PROs) and questionnaires, blood, urine, allergy skin prick testing, skin swab, and pulmonary function testing to include fractional exhaled nitric oxide testing (FeNO)."
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 collects health data, blood, fluids, and tissue samples to help researchers learn how to prevent and treat allergic and sinus diseases. It is for people ages 3 to 100 with these or other listed health problems. Participants may have follow-up visits for up to 3 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 3 to 100 years old.
  • Have a suspected or confirmed allergy-related, breathing, nose, or sinus disorder, or a history of a suspected or confirmed disorder of the immune system, which fights disease. You may also qualify if you have had a fast allergic reaction to something in the air, food, insect stings, or medicine.
  • Be able to give informed consent, meaning you understand and agree to join the study.
  • Have or be willing to get a primary doctor outside the National Institutes of Health (NIH) to manage your health and handle emergency care if needed.
  • Allow your samples and study data to be stored for future medical research.

Who can't join

  • You cannot join if the study doctor thinks a physical or mental health condition makes participation unsuitable.
  • Extra skin tissue samples cannot be taken if you are under 18, pregnant, or have a history of keloids, which are raised scars.
  • Extra tissue samples from nose or sinus polyps cannot be taken if you are under 18, pregnant, or taking blood thinners that have not been stopped for the procedure. Polyps are growths inside the nose or sinuses.
  • Allergy skin prick tests cannot be done if you are pregnant.
  • Tissue sampling through a viewing tube, called an endoscopic biopsy, cannot be done if you are under 18, pregnant, breastfeeding, or have had recent belly surgery.
  • Endoscopic biopsy cannot be done if you have uncontrolled asthma, a severe illness rated ASA class 3 or higher, or very low blood oxygen caused by long-term lung disease.
  • Endoscopic biopsy cannot be done if you have had a bad reaction to the sedation or anesthesia needed for the procedure. These medicines help you relax or sleep.
  • Endoscopic biopsy cannot be done if your hemoglobin, which carries oxygen in blood, is below 11 g/dL; your platelets, which help blood clot, are below 100,000 per microliter; or you cannot pause blood-thinning medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1)Aged 3 to 100 years. 2a) Suspected or confirmed allergic, atopic, respiratory, or nasal/sinus disorder or have suspected or confirmed history of an immune dysregulatory disorder, OR 2b) Have a clinical history of an immediate hypersensitivity reaction to aeroallergens, food, insect stings, or medications. 3\) Able to provide informed consent. 4\) Have or are willing to obtain a non-NIH primary physician who will manage all health conditions and be responsive for emergency medical treatment, if required. 5\) Willing to allow storage of blood, skin swabs, nasal fluid/brushings, bodily fluids, and other clinically appropriate tissue specimens or data generated during participation for future use in medical research. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study. 2. For additional skin biopsies only: 1. Individuals who have a history of keloid formation 2. Children (\<18 years old) 3. Participants who are pregnant 3. For additional nasal-sinus polyp biopsies only: 1. Individuals on blood thinners unless they have already been stopped for the procedure 2. Children (\<18 years old) 3. Participants who are pregnant 4. For skin prick testing a. Participants who are pregnant. 5. Endoscopic Biopsy 1. Uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist's Physical Status Classification System (https://www.asahq.org/standards-and-practice-parameters/statement-on-asaphysical-status-classification-system) 2. History of adverse reaction to conscious sedation or general anesthesia required for endoscopy 3. Hemoglobin \< 11 g/dL 4. Platelet count \< 100,000 microL 5. Pregnant or breastfeeding 6. Severe hypoxemia due to chronic pulmonary disease 7. Recent abdominal surgery 8. Anticoagulant therapy that cannot be interrupted 9. Younger than 18 years of age Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, gender, race, ethnicity, sexual orientation, or socioeconomic status.

Study sites (1)

MD