Biorepository for people with allergic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to collect data and biological samples from individuals aged 3 to 100 years who have allergic or sinus diseases. Participants will undergo clinical evaluations and provide samples such as blood, nasal fluid, and skin swabs during their visits to the NIH Clinical Center. The collected samples will be stored in a biorepository for future research on allergic conditions and may also be used to recruit control patients for ongoing clinical studies. The study will last between 1 to 3 years, with participants having at least one clinic visit and potentially annual follow-ups.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Paneez Khoury, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Hye Jeong C Bolan, R.N.
• Email: NIAIDMADREP@NIH.GOV
• Phone: (301) 594-1233

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.