Integration of Family Health History Data Into a Singaporean Healthy Population Cohort Database to Understand the Associations Between Family Health History and Genomics
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedades hemáticas y linfáticas+7
+ Enfermedades Hematológicas
+ Enfermedades del sistema inmunitario
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 23 de julio de 2017
Fecha en la que se inscribió al primer participante.This study is a collaboration between Duke University School of Medicine Center for Applied Genomics and Precision Medicine (CAGPM) and the National Heart Center of Singapore (NHCS) and SingHealth Duke-NUS Center for Precision Medicine (PRISM). The NHCS study, Molecular and Imaging Studies of Cardiovascular Health and Disease ("Biobank study") is collecting genomic, clinical, and environmental data on a large cohort of healthy Singaporean volunteers. Data from the Biobank study is being deposited into a large healthy population cohort database, SPECTRA, organized under PRISM. The investigators will collaborate with the NHCS Biobank study and PRISM to integrate the Duke family history risk assessment platform, MeTree, into the data collection of the Biobank study cohort for in-depth analyses of FHH and genomic associations as well as exploration of the feasibility of MeTree implementation into the Singaporean clinical context. The Biobank study is a prospective observational study. It has already enrolled 1,000 subjects and will continue enrollment over the next year and possibly beyond. Previously enrolled subjects will be re-contacted for completion of MeTree as well as having future enrollees complete the tool prospectively. The investigators anticipate 5,000 subjects completing MeTree over a one-year period. The investigators will evaluate the feasibility and effectiveness of implementing MeTree in the larger Singaporean context. The investigators will assess implementation related outcomes- questions/problems people have when completing their family histories, how complete are the FHH entered, what types of risk are identified and what existing programs in Singapore are designed to manage that risk. The completion of this project will provide a significant amount of data to better understand the associations between FHH and genomic data within a healthy Asian population. It also will result in a better understanding of an appropriate implementation strategy for MeTree within the Singaporean clinical setting. Specific Aim 1: To explore the correlation of genomic data and FHH within a healthy Asian population. Specific Aim 2: To assess the clinical utility and appropriateness of a patient-entered FHH risk assessment tool within a Singaporean population. Specific Aim 3: To create an implementation strategy for broader implementation of a patient-driven risk assessment tool in Singapore. Duke University will be providing access to the MeTree Family Health History tool, storage of the PRISM participant data, participant and provider risk assessment reports, and education about the tool to PRISM study staff as needed. Duke University personnel will not be involved in any recruiting, consenting, or follow-up with study participants, but will have access to de-identified participant data housed in the MeTree research database in order to provide support for the study coordinators for participant account trouble-shooting and also to provide interim and final datasets to the PRISM statisticians. The MeTree research database currently sits on a DHTS server behind the Duke firewall, and is maintained and secure in accordance with Duke policy for patient data.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 1000 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 16 a 90 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Healthy Singaporeans enrolled or eligible for enrollment in a local Biobank protocol Exclusion Criteria: \-
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Heart Centre of Singapore
Singapore, SingaporeAbrir National Heart Centre of Singapore en Google Maps