Registry for Asthma Characterization and Recruitment 2 (RACR2)
Registry for Asthma Characterization and Recruitment 2 (ICAC-25)
Přehled studie
Postavení
Podmínky
Detailní popis
The overall goal of the Registry for Asthma Characterization and Recruitment 2 (RACR2) is to create a database of participants who are potentially eligible for future Inner City Asthma Consortium (ICAC) clinical research studies. The registry will provide an avenue to assess various asthma and allergy characteristics, which will result in more efficient recruitment for current and future ICAC protocols.
Potential participants will be recruited via telephone or in person. Those deemed potentially eligible for a current protocol or protocol in development may be invited to the clinic for further data collection and assessments. This registry allows flexibility in selecting the eligibility criteria and data collection to match planned or upcoming ICAC protocols. At each stage of data collection, participants may be discontinued, put on hold, or invited to participate in further screening activities, depending on the likelihood that they will qualify for a future protocol. Participants may opt to withdraw their information or discontinue from the registry at any time, in person, by telephone, or in writing.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- Children's Hospital Colorado
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20010
- Children's National Medical Center
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Illinois
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Chicago, Illinois, Spojené státy, 60611
- Ann and Robert Lurie Children's Hospital of Chicago
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Maryland
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Baltimore, Maryland, Spojené státy, 21205
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02118
- Boston Medical Center
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Michigan
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Detroit, Michigan, Spojené státy, 48202
- Henry Ford Health System
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Missouri
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Saint Louis, Missouri, Spojené státy, 63110
- St. Louis Children's Hospital
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New York
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New York, New York, Spojené státy, 10032
- Columbia University Medical Center
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Ohio
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Cincinnati, Ohio, Spojené státy, 452229
- Cincinnati Children's Hospital
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Texas
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Dallas, Texas, Spojené státy, 75390
- University of Texas Southwestern Medical School
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Eligibility criteria vary depending on recruitment needs for future ICAC protocols. Participants with asthma and participants without asthma, atopy, and rhinitis may be recruited at the same time or different times, depending on recruitment needs.
Certain characteristics or groups of characteristics within each criterion may be selected for periods of time across clinical sites or at each individually participating clinical site. For example, over a 6-month period, the Consortium could decide to recruit children aged 6 through 12 years with diagnosed asthma who have asthma symptoms, have a history of an asthma exacerbation, and reside in prespecified census tracts within the metropolitan statistical area. During selective recruitment periods, individuals who meet broader criteria may or may not be enrolled at the discretion of the Consortium.
- All participants must resides within the metropolitan statistical area that includes the clinical site.
Participants with asthma are defined by having evidence of asthma. Evidence of asthma is defined by meeting at least one of the following criteria:
- Clinician-diagnosed asthma
- Asthma symptoms, history of an asthma exacerbation, or current use of asthma medication(s)
- Recurrent wheezing
- Wheezing apart from a cold
At times of selective recruitment, participants with asthma may be required to meet more selective criteria above and may be required to meet one or more of the criteria in risk factors for asthma. Evidence of risk factors for asthma is defined by meeting at least one of the following criteria:
- Parental history of asthma
- Eczema or atopic dermatitis
- Reported allergies to pets, food, indoor allergens, or outdoor allergens
- Allergic sensitization by results of allergy skin testing or results of serum immunoglobulin E (IgE) testing
- Rhinitis
Participants without asthma, atopy, and rhinitis must meet all of the following:
- Negative history of an asthma diagnosis by a clinician
- Negative history of a diagnosis of atopic dermatitis or eczema by a clinician
- Negative history of a rhinitis diagnosis by a clinician
- A forced expiratory volume at 1 second (FEV1) >= 5% predicted
- Negative prick skin-tests to any of a panel of indoor and outdoor allergens
- No current asthma as determined by the appropriate case report form
- No current chronic rhinitis/sinusitis as determined by the appropriate case report form
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from enrollment:
- Has any of the following chronic medical conditions: cardiac condition requiring daily medication, seizure disorder requiring daily medication, obvious severe mental retardation that prevents the participant from answering questions or following instructions, cystic fibrosis, immune deficiency, type 1 diabetes, allergic bronchopulmonary aspergillosis, or any other chronic medical condition at the discretion of the registry clinician
- Does not primarily speak English (or Spanish at clinical sites with Spanish-speaking staff)
- Has a primary caretaker who does not speak English (or Spanish at clinical sites with Spanish-speaking staff; not applicable if participant is able to provide consent)
- Is a foster child (not applicable if participant is able to provide consent)
- Is unwilling to sign the written informed consent form if of age, or parent/legal guardian is unwilling to sign the written informed consent if participant is not of age
- Is unwilling to sign the assent form, if age appropriate
Participants who are pregnant will not be excluded or discontinued from RACR2 but will not undergo any procedures that are prohibited during pregnancy.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of participants with asthma and allergy characteristics
Časové okno: Year 7
|
Characteristics of the participants enrolled in the registry will be assessed on a periodic basis (descriptive summary of diagnosis and parameters associated with the former).
|
Year 7
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jacqueline Pongracic, M.D., Ann & Robert H Lurie Children's Hospital of Chicago
- Vrchní vyšetřovatel: Edward M. Zoratti, M.D., Henry Ford Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DAIT ICAC-25
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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