RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-28
Study Completion:2045-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06732414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 3 to 100 years.
  2. * a) Suspected or confirmed allergic, atopic, respiratory, or nasal/sinus disorder or have suspected or confirmed history of an immune dysregulatory disorder, OR
  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.
  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:
  3. * a. Individuals who have a history of keloid formation
  4. * b. Children (\<18 years old)
  5. * c. Participants who are pregnant
  6. * For additional nasal-sinus polyp biopsies only:
  7. * a. Individuals on blood thinners unless they have already been stopped for the procedure
  8. * b. Children (\<18 years old)
  9. * c. Participants who are pregnant
  10. * For skin prick testing
  11. * Endoscopic Biopsy
  12. * a. Uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s Physical Status Classification System
  13. * b. History of adverse reaction to conscious sedation or general anesthesia required for endoscopy
  14. * c. Hemoglobin \< 11 g/dL
  15. * d. Platelet count \< 100,000 microL
  16. * e. Pregnant or breastfeeding
  17. * f. Severe hypoxemia due to chronic pulmonary disease
  18. * g. Recent abdominal surgery
  19. * h. Anticoagulant therapy that cannot be interrupted
  20. * i. Younger than 18 years of age

Contacts and Locations

Study Contact

Hye Jeong C Bolan, R.N.
CONTACT
(301) 594-1233
NIAIDMADREP@NIH.GOV
Paneez Khoury, M.D.
CONTACT
(301) 402-3673
paneez.khoury@nih.gov

Principal Investigator

Paneez Khoury, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Paneez Khoury, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-28
Study Completion Date2045-11-01

Study Record Updates

Study Start Date2025-01-28
Study Completion Date2045-11-01

Terms related to this study

Keywords Provided by Researchers

  • Allergy, repository, data, sample collection

Additional Relevant MeSH Terms

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