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Идёт набор NCT06057181

Helix Research Network

— Наблюдательное Genetic Predisposition to Disease Genetics Disease

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
В протоколе указаны: Exome sequencing.
Кому может быть актуально
Состояния в реестре: Genetic Predisposition to Disease, Genetics 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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Обзор

The Helix Research Network ("HRN") is a network of academic, public, and/or private healthcare organizations that are committed to advancing medical research and improving human health through large-scale genomics research and acceleration of the integration of genomic and other omics data into clinical care.

Подробное описание

The network will create a large-scale clinicogenomics dataset, which will support research to discover molecular and genetic determinants of disease risk, disease progression, treatment response, health economic outcomes, social or behavioral determinants of health, targets for therapeutic intervention, risk stratification, clinical implementation, and other clinical indicators of interest. This clinicogenomics dataset will be used to reveal molecular and/or genetic factors that could improve the diagnosis or medical treatment of individual participants and includes a process to share individual results with participants. Participants will also receive annual reports on study outcomes and the impact of HRN, as such information becomes available.

Institutional membership in HRN will consist of Helix and member healthcare systems (herein referred to as "HRN Member Site(s)"). The Helix Research Network is a multi-center research program that will enroll an unlimited number of participants. Participants will be recruited concurrently from HRN Member Sites. In some cases, HRN Member Sites may recruit participants from multiple clinical sites. Participants who meet the enrollment criteria established in this protocol will be enrolled if they or their legally authorized representative(s) provide informed consent in accordance with all applicable regulations and sIRB requirements. Participants will be enrolled until withdrawal from the study or end of the study. Participants may be recruited at any point during the study period, until the recruitment goals established by the protocol are met.

Вмешательства

  • Генная терапия Exome sequencing
    Exome sequencing will be completed on each sample submitted.

Первичные конечные точки

  • Establish a Research Network [Срок оценки: Through study completion, average 10 years]
  • Aggregate data [Срок оценки: Through study completion, average 10 years]
  • Re-Contact participants [Срок оценки: Through study completion, average 10 years]
  • Genetic biomarker identification [Срок оценки: Through study completion, average 10 years]
  • Exploration of genetic determinants of disease [Срок оценки: Through study completion, average 10 years]
  • Collection and analysis of Patient Reported Outcomes [Срок оценки: Through study completion, average 10 years]

Критерии участия

Критерии включения

  • 18 years and older
  • Willing and able to comply with all aspects of the protocol

Критерии исключения

  • History of allogenic bone marrow transplant
  • History of allogenic stem cell transplant
  • Anything that would place the individual at increased risk or preclude an individual's: 1) full compliance with study requirements; or 2) completion of the study based on the assessment from local consenting and enrolling Investigators.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Экологическое

Центры проведения

США · 14 центров
  • Parkview Health (DNA Insights) — Fort Wayne
  • HealthPartners (myGenetics) — Bloomington
  • Nebraska Medicine - University of Nebraska Medical Center (Genetic Insights Project) — Omaha
  • Renown Health (Healthy Nevada Project) — Reno
  • Rochester Regional Health (GenoWell) — Rochester
  • Cone Health (Gene Connect) — Burlington
  • WakeMed (PreciselyYou) — Raleigh
  • TriHealth (DNA Discovery) — Cincinnati
  • … и ещё 6 центров

Идентификаторы

NCT: NCT06057181 · HRN 001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗