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Идёт набор NCT01354002

Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility

— Наблюдательное Normal and Diseased Tissue and Body Fluids Samples

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: Normal and Diseased Tissue and Body Fluids Samples. 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

TBANK: Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility

Обзор

The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from relatives of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding clinical and laboratory data on disease characterization, treatment, and outcome; and to serve as a source of human biological samples and corresponding laboratory and clinical data.

Подробное описание

There is no study design for this protocol. Samples obtained under IRB/IEC-approved protocols that clearly permit storage of patient material at SJCRH will be banked, provided proof of informed consent is available. Such samples will be tagged accordingly and will be only released to fulfill the aim(s) of the protocol under which they were obtained, or to investigators that apply to the St. Jude Children's Research Hospital Tissue Resources Committee to use the samples.

Первичные конечные точки

  • Collecting, processing and archiving human tissue [Срок оценки: Samples will be stored indefinitely.]

Критерии участия

Критерии включения

  • Patients (and their relatives) and control populations treated or studied at SJCRH and SJCRH affiliates and collaborating sites that have IRB approval for TBANK with malignant and non-malignant conditions.
  • Patients from institutions that do not have Institutional Review Board (IRB) approval for TBANK, and at which a banking mechanism may not be established, who provide samples for research at St. Jude and from whom consent for TBANK is obtained by the TBANK principal investigator (PI).
  • Samples from employees of St. Jude Children's Research Hospital (SJCRH) collected for public health surveillance studies (e.g. SJTRC-NCT04362995) provided the employees have consented to participate in the specific IRB-approved studies.

Критерии исключения

  • Patients from institutions that do not have IRB approval for TBANK, and who have not provided consent for TBANK, or patients not enrolled on SJCRH protocols that incorporate consent for tumor banking.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 14 центров
  • St. Jude Clinic at Huntsville Hospital for Women & Children — Huntsville
  • Lucile Packard Children's Hospital Stanford University — Palo Alto
  • Rady Children's Hospital and Health Center — San Diego
  • Children's Hospital of Illinois at OSF-Saint Francis Medical Center — Peoria
  • Our Lady of the Lake Regional Medical Center — Baton Rouge
  • Louisiana State University Health Sciences Center — Shreveport
  • Children's Hospital of Michigan — Detroit
  • Mercy Children's Hospital - Springfield — Springfield
  • … и ещё 6 центров

Публикации

  • Maciaszek JL, Oak N, Chen W, Hamilton KV, McGee RB, Nuccio R, Mostafavi R, Hines-Dowell S, Harrison L, Taylor L, Gerhardt EL, Ouma A, Edmonson MN, Patel A, Nakitandwe J, Pappo AS, Azzato EM, Shurtleff SA, Ellison DW, Downing JR, Hudson MM, Robison LL, Santana V, Newman S, Zhang J, Wang Z, Wu G, Nichols KE, Kesserwan CA. Enrichment of heterozygous germline RECQL4 loss-of-function variants in pediat PMID 31604778

Идентификаторы

NCT: NCT01354002 · TBANK

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗