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Trial record 3 of 557 for:    Genetic AND family history

Family History in a Singaporean Healthy Population

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ClinicalTrials.gov Identifier: NCT03114553
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to better understand the linkages between family health history (FHH) and genomics in a Singaporean population. Secondly this study will evaluate the facilitators and barriers to implementation of a family history collection and risk assessment tool within a Singaporean population.

Condition or disease Intervention/treatment
All Genetic: MeTree

Detailed Description:

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 1,000 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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integration of Family Health History Data Into a Singaporean Healthy Population Cohort Database to Understand the Associations Between Family Health History and Genomics
Actual Study Start Date : July 23, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • Genetic: MeTree
    Software program collecting family health history and generating clinical decision support for risk-based preventive care
    Other Name: patients in the database have already had biologic specimens for genetic analysis


Primary Outcome Measures :
  1. Correlation of genomic data and family health history (FHH) within a healthy Asian population. [ Time Frame: Baseline ]
    assess whether family history driven risk results correlate with findings on genetic results


Secondary Outcome Measures :
  1. Clinical utility and appropriateness of a patient-entered FHH risk assessment tool within a Singaporean population [ Time Frame: Baseline ]
    Determine whether US guideline driven risk assessment has any clinical value in Singapore

  2. Facilitators and barriers to using systemic risk assessment tool in Singapore [ Time Frame: Baseline ]
    Identify facilitators and barriers to using risk assessment tool in order to create a strategy for broader implementation of a patient-driven risk assessment tool in Singapore


Biospecimen Retention:   None Retained
blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Singaporean population
Criteria

Inclusion Criteria:

  • Healthy Singaporeans enrolled or eligible for enrollment in a local Biobank protocol

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114553


Contacts
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Contact: Lori Orlando, MD 919 660-6606 lori.orlando@duke.edu
Contact: Rayanne Wu, MD 919 668-7205 ryanne.wu@duke.edu

Locations
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Singapore
National Heart Centre of Singapore Recruiting
Singapore, Singapore, 574116
Contact: Ryanne R Wu, MD       ryann.wu@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Lori Orlando, MD Associate Professor of Medicine

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03114553     History of Changes
Other Study ID Numbers: Pro00079760
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
family health history
prevention
genetic risk
clinical decision support