Caris Biorepository Research Protocol
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: Cancer, Early Detection of Cancer, Minimal Residual Disease. Базовые параметры: от 18 лет · 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
The Caris Biorepository Research Protocol
Обзор
The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients. The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time.
Подробное описание
The Caris Biorepository is an effort toward defining the future of medicine incorporating the discoveries of the genomic era by providing physicians, researchers and scientists access to quality human specimens and data aimed at improving human health and fighting disease. This will be accomplished through acquiring and sharing valuable biospecimen information and clinical outcomes in a collaborative, secure environment. The Caris Biorepository will bridge the gap and correlate human specimens with clinical and specimen data valuable to multiple and varying entities interested in advancing science with precision medicine by targeting disease treatments.
The objective of this project is to develop and implement a state-of-the-science Biorepository that ensures molecular integrity and clinical relevance of human biospecimens used in research and clinical medicine. The Caris Biorepository will also provide vital biospecimens and data to internal researchers and external research collaborators such as government, academia and industry collaborators for the use of drug development discoveries, clinically relevant research trials, publications and posters, and the implementation of future healthcare policies. This project may also impact characterization of trends in practice patterns and their relation to patient outcomes as well as the economic implications of differing evaluation, treatment and management paradigms.
Первичные конечные точки
- Develop biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated clinical data. [Срок оценки: 35 years]
- Implement release of specimens from biorepository for testing [Срок оценки: 35 years]
Вторичные конечные точки (6)
- Laboratory testing [Срок оценки: 35 years]
- Laboratory testing [Срок оценки: 35 years]
- Laboratory testing [Срок оценки: 35 years]
- Laboratory testing [Срок оценки: 35 years]
- Laboratory testing [Срок оценки: 35 years]
- Laboratory testing [Срок оценки: 35 years]
Критерии участия
Критерии включения
- 18 years of age or older
- Capacity to provide informed consent
Критерии исключения
- Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients will not be approached for participation in the Caris Biorepository.
- Minor subjects will not be included in the Caris Biorepository, as it is possible biospecimens and data may be stored beyond the time limitations of assent and it may be impracticable to re-consent these subjects once they become adults.
- Individuals who lack the capacity to give informed consent
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 · 38 центров
- University of South Alabama — Mobile
- Southwest Medical Imaging — Scottsdale
- St. Bernards Medical Center — Jonesboro
- CARTI Cancer Center — Little Rock
- ObjectiveHealth - ARcare Center for Clinical Research — Little Rock
- Lee Memorial Health System — Fort Myers
- Cancer Care of North Florida — Lake City
- Advent Health — Orlando
- … и ещё 30 центров
Идентификаторы
NCT: NCT01499394 · TCBIO-001-0710