Biorepository for people with allergic diseases
A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-up
This study is collecting samples and information from people with allergies or sinus issues to help researchers learn more about these conditions and improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 3 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06732414 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 3 to 100 years with suspected or confirmed allergic or atopic conditions.
Not a fit: Patients without any allergic or atopic conditions or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding and treatment options for various allergic diseases.
How similar studies have performed: Other studies have successfully utilized biorepositories for allergic diseases, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.