AllNCT03114553
Family History in a Singaporean Healthy Population
An observational study of All, run by Duke University at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- All
- What is being tested?
- MeTree
- How many people
- 1,000 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Jul 2017to 10 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy Singaporean population
Who may be able to join
- Healthy Singaporeans enrolled or eligible for enrollment in a local Biobank protocol
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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.
- Conditions
- All
- Being tested
- MeTree
- Keywords
- family health history, prevention, genetic risk, clinical decision support
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeTreeGenetic
Also called patients in the database have already had biologic specimens for genetic analysis
Software program collecting family health history and generating clinical decision support for risk-based preventive care
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of genomic data and family health history (FHH) within a healthy Asian population.
assess whether family history driven risk results correlate with findings on genetic results
Measured: Baseline
Secondary outcomes (2)
Clinical utility and appropriateness of a patient-entered FHH risk assessment tool within a Singaporean population
Determine whether US guideline driven risk assessment has any clinical value in Singapore
Measured: Baseline
Facilitators and barriers to using systemic risk assessment tool in Singapore
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start23 Jul 2017
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AllStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Orlando, MD, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114553
- Sponsor's protocol ID
- Pro00079760
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2017
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu RR, Sultana R, Bylstra Y, Jamuar S, Davila S, Lim WK, Ginsburg GS, Orlando LA, Yeo KK, Cook SA, Tan P. Evaluation of family health history collection methods impact on data and risk assessment outcomes. Prev Med Rep. 2020 Mar 5;18:101072. doi: 10.1016/j.pmedr.2020.101072. eCollection 2020 Jun.
PubMed 32181122Bylstra Y, Lim WK, Kam S, Tham KW, Wu RR, Teo JX, Davila S, Kuan JL, Chan SH, Bertin N, Yang CX, Rozen S, Teh BT, Yeo KK, Cook SA, Jamuar SS, Ginsburg GS, Orlando LA, Tan P. Family history assessment significantly enhances delivery of precision medicine in the genomics era. Genome Med. 2021 Jan 7;13(1):3. doi: 10.1186/s13073-020-00819-1.
PubMed 33413596
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03114553
- Acronym / sponsor ID
- Pro00079760
- Conditions
- All
- Keywords
- family health history, prevention, genetic risk, clinical decision support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 23 Jul 2017 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy Singaporean population
Key inclusion criteria (1 listed)
- Healthy Singaporeans enrolled or eligible for enrollment in a local Biobank protocol
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeTreeAlso: patients in the database have already had biologic specimens for genetic analysisSoftware program collecting family health history and generating clinical decision support for risk-based preventive care | Genetic | – |
Primary outcome
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
2 secondary outcomes
Clinical utility and appropriateness of a patient-entered FHH risk assessment tool within a Singaporean population
Time frame: Baseline
Facilitators and barriers to using systemic risk assessment tool in Singapore
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 32181122Wu RR, Sultana R, Bylstra Y, Jamuar S, Davila S, Lim WK, Ginsburg GS, Orlando LA, Yeo KK, Cook SA, Tan P. Evaluation of family health history collection methods impact on data and risk assessment outcomes. Prev Med Rep. 2020 Mar 5;18:101072. doi: 10.1016/j.pmedr.2020.101072. eCollection 2020 Jun.
- Results publication: PubMed 33413596Bylstra Y, Lim WK, Kam S, Tham KW, Wu RR, Teo JX, Davila S, Kuan JL, Chan SH, Bertin N, Yang CX, Rozen S, Teh BT, Yeo KK, Cook SA, Jamuar SS, Ginsburg GS, Orlando LA, Tan P. Family history assessment significantly enhances delivery of precision medicine in the genomics era. Genome Med. 2021 Jan 7;13(1):3. doi: 10.1186/s13073-020-00819-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Orlando, MD principal investigator
Associate Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All, run by Duke University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of genomic data and family health history (FHH) within a healthy Asian population. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.