[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572372":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":11,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":11,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"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.",null,"20 years",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":14,"timePerspective":15,"maskingInfo":11},"COHORT","PROSPECTIVE","Study Description:\n\nThis 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\u002For send-in samples. This repository will provide atopic participant samples for translational studies performed by NIH investigators or their collaborators and also serve as a means for recruiting atopic control patients to ongoing NIAID and National Institute on Deafness and Other Communication Disorders (NIDCD) clinical studies.\n\nParticipants aged 3 and older will present to the NIH CC for visits for clinical evaluation and treatment of allergic diseases as appropriate. Data and samples obtained but not utilized from clinically indicated procedures will be put into the repository (e.g. physical exams, nasal endoscopy, blood tests, olfaction assessment, and nasal sinus polyp biopsy where appropriate).\n\nSamples that may be collected prospectively for inclusion in the repository include nasal brushings, nasal lining fluid, blood, urine, and skin swabs. 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). Data\u002Fsamples from clinical procedures will also be collected for the repository, where possible.\n\nAlthough standard of care treatment may be initiated and monitored under this protocol, it will be expected that after a set number of visits outlined in the manual of operations, continued medication prescribing and monitoring will be transitioned to the referring provider, the patient s outside primary physician or allergist-immunologist, or another NIH protocol depending on the patient condition and importance for biorepository collection. No experimental treatments will be offered under this protocol.\n\nObjective:\n\nTo 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.","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.",[19,22,25],{"label":20,"type":11,"description":21,"interventionNames":11},"Conditions that may be initially evaluated or managed by A&I but not categorized in 1 or 2 above","Conditions that may be initially evaluated or managed by an allergist-immunologist or rhinologist but not categorized in (1) or (2) above (eg, hypereosinophilia, mast cell disorders, pruritus, chronic cough, smell disorders)",{"label":23,"type":11,"description":24,"interventionNames":11},"Individuals with a suspected allergic or atopic disease","Individuals with a suspected allergic or atopic disease, but without demonstrated allergen sensitization (eg, contact hypersensitivity, chronic spontaneous urticaria, drug allergy)",{"label":26,"type":11,"description":27,"interventionNames":11},"Individuals with an allergic, atopic, or sinus disease","Individuals with an allergic, atopic, or sinus disease (eg, atopic dermatitis, eosinophilic esophagitis (EoE), asthma, chronic rhinosinusitis with polyposis) with documented allergen sensitization in the skin or blood",[29],{"name":30,"affiliation":31,"role":32},"Paneez Khoury, M.D.","National Institute of Allergy and Infectious Diseases (NIAID)","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Hye Jeong C Bolan, R.N.","CONTACT","(301) 594-1233","NIAIDMADREP@NIH.GOV",{"name":30,"role":36,"phone":40,"phoneExt":11,"email":41},"(301) 402-3673","paneez.khoury@nih.gov",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-77.10026,38.98067,{"lat":55,"lon":54},[58,63],{"name":59,"role":36,"phone":60,"phoneExt":61,"email":62},"NIH Clinical Center Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"name":64,"role":36,"phone":37,"phoneExt":11,"email":65},"Hye Jeong Bolan, M.S.N.","bolanhy@mail.nih.gov",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100572372","a-biorepository-of-multiple-allergic-diseases-madrep-with-longitudinal-follow-up-100572372",false,"NCT06732414","A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up","A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-up","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1)Aged 3 to 100 years.\n\n2a) Suspected or confirmed allergic, atopic, respiratory, or nasal\u002Fsinus disorder or have suspected or confirmed history of an immune dysregulatory disorder, OR\n\n2b) Have a clinical history of an immediate hypersensitivity reaction to aeroallergens, food, insect stings, or medications.\n\n3\\) Able to provide informed consent.\n\n4\\) 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.\n\n5\\) Willing to allow storage of blood, skin swabs, nasal fluid\u002Fbrushings, bodily fluids, and other clinically appropriate tissue specimens or data generated during participation for future use in medical research.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n1. Any condition(s) or diagnosis, physical and\u002For psychological, that the investigator feels precludes the patient from participation in the study.\n2. For additional skin biopsies only:\n\n   1. Individuals who have a history of keloid formation\n   2. Children (\\\u003C18 years old)\n   3. Participants who are pregnant\n3. For additional nasal-sinus polyp biopsies only:\n\n   1. Individuals on blood thinners unless they have already been stopped for the procedure\n   2. Children (\\\u003C18 years old)\n   3. Participants who are pregnant\n4. For skin prick testing\n\n   a. Participants who are pregnant.\n5. Endoscopic Biopsy\n\n   1. Uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist's Physical Status Classification System (https:\u002F\u002Fwww.asahq.org\u002Fstandards-and-practice-parameters\u002Fstatement-on-asaphysical-status-classification-system)\n   2. History of adverse reaction to conscious sedation or general anesthesia required for endoscopy\n   3. Hemoglobin \\\u003C 11 g\u002FdL\n   4. Platelet count \\\u003C 100,000 microL\n   5. Pregnant or breastfeeding\n   6. Severe hypoxemia due to chronic pulmonary disease\n   7. Recent abdominal surgery\n   8. Anticoagulant therapy that cannot be interrupted\n   9. Younger than 18 years of age\n\nParticipants 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.","ALL","3 Years","100 Years",{"count":79,"type":80},10000,"ESTIMATED","OBSERVATIONAL","Background:\n\nAllergic 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.\n\nObjective:\n\nTo collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases.\n\nEligibility:\n\nPeople aged 3 to 100 years with allergic or sinus diseases.\n\nDesign:\n\nParticipants 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:\n\n* Blood will be collected.\n* 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.\n* Skin cells will be collected by rubbing with a cotton swab.\n* A urine sample will be collected.\n* 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).\n* Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs.\n* 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.\n* Participants will complete online questionnaires regarding their symptoms, health, and life.\n\nParticipants may return for more visits for up to 3 years.",[84],"Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a",[86],"Allergy, repository, data, sample collection","2026-10-08",{"date":89,"type":90},"2026-10-09","ACTUAL",{"date":92,"type":90},"2025-01-28",{"date":94,"type":80},"2045-11-01",{"name":31,"class":6},1]