NCT06278883: GRACE

Genomic Medicine Risk Assessment Care for Everyone - Implementation Phase

Completed NA Last updated 9 April 2026

What this trial tests

NA trial testing Disease Risk Assessment in Cardiovascular Diseases in 245 participants. Completed in 10 September 2025.

Timeline

3 June 2024

Primary endpoint
10 September 2025

10 September 2025

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	245
Start date	3 June 2024
Primary completion	10 September 2025
Estimated completion	10 September 2025
Sites	4 locations across United States

Drugs / interventions tested

• Disease Risk Assessment

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Cancer — all drugs for Cancer →
• Liver Diseases — all drugs for Liver Diseases →
• Hyperthermia — all drugs for Hyperthermia →

Sponsor

Duke University

Who can join

18 and older, any sex, with Cardiovascular Diseases or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The three primary aims are:

Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.

Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.

Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.

Three sets of participants will be engaged: patients (n=750), providers (n=25), and family members of "probands" (i.e., patients that have a genetic change that increases risk, n\~500).

Patient participants will be asked to complete a baseline survey, enter their family health history information into MeTree (a family health history web-based platform) and complete a survey about their experience using the platform. Subsequent study procedures will depend on: 1) the results of their MeTree risk evaluation, 2) their acceptance/declination of genetic testing (for those categorized as needing testing by MeTree), and 3) the results of the test (for those accepting testing).

Provider participants will be providers who are the primary care physicians treating one or more patients enrolled in the patient participant group. Providers will be notified on a patient by patient basis once the patient participant under their care has complete the risk assessment process and the risk report is available from MeTree. At study completion, provider participants will be asked to complete a survey about their demographics, practice, and experiences with the study.

Blood relatives of the probands who are identified by the proband as open to engaging with the study will be contacted and offered genetic counseling and genetic testing.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.