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Идёт набор NCT05272241

Registry of Asthma Characterization and Recruitment 3 (RACR3)

— Наблюдательное Asthma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Asthma. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)

Обзор

This is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies.

Подробное описание

Protocol CAUSE-02 RACR3 is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies. Approximately 1,500 participants - of all ages, living in selected Office of Management and Budget (OMB) defined Metropolitan Statistical Areas (MSAs) will be enrolled in the registry.

The registry database will be generated with data gathered at a single core visit, followed by optional additional visits. The registry will include assessments of various asthma and allergy characteristics to achieve a more flexible, efficient, selective, and inclusive approach to participant recruitment while still following national guidelines to foster participant safety. CAUSE investigators may invite children or adults without asthma or atopic diseases to participate in the registry as "healthy" controls; for validation of laboratory tests, study monitoring equipment, and/or procedures; or for site procedure training of study personnel for certification and quality assurance.

Participants may opt to withdraw their information or discontinue from the registry at any time, in person, by telephone, or in writing.

Первичные конечные точки

  • Number of participants with asthma and allergy characteristics [Срок оценки: 7 years]

Критерии участия

Критерии включения

  • Participant is either:
  • At least 18 years old, willing and able to provide informed consent at the time of enrollment
  • Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment
  • Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)

Критерии исключения

  • Participant does not speak English or Spanish and/or guardian does not speak English or Spanish
  • Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up
  • Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study

Participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy.

Potential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 7 центров
  • Children's Hospital Colorado: Allergy Program — Aurora
  • Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research — Washington D.C.
  • Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology — Chicago
  • Boston Children's Hospital: Department of Immunology — Boston
  • Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Insti — New York
  • Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy — New York
  • Cincinnati Children's Hospital Medical Center: Asthma Center — Cincinnati

Идентификаторы

NCT: NCT05272241 · DAIT CAUSE-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗