NCT04178122

Brief Summary

The purpose of the Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study is to develop a process to return medically actionable genetic results to living MVP participants nationwide and to determine the impact of doing so on medical management and outcomes and Veteran quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 16, 2025

Completed
Last Updated

October 16, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

November 20, 2019

Results QC Date

September 8, 2025

Last Update Submit

September 30, 2025

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • LDL-C Change

    Change in LDL-C after 6 months.

    6 months

Secondary Outcomes (2)

  • LDL-C Target

    6 months

  • Pharmacotherapy

    6 months

Other Outcomes (5)

  • Cascade Testing

    6 months

  • Lifestyle Behaviors

    6 months

  • Quality of Life (Veterans RAND Survey)

    6 months

  • +2 more other outcomes

Study Arms (2)

Immediate Results

EXPERIMENTAL

Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.

Genetic: Result disclosure

Delayed Results

EXPERIMENTAL

Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.

Genetic: Result disclosure

Interventions

Result disclosureGENETIC

Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

Delayed ResultsImmediate Results

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living enrollee in MVP
  • Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data

You may not qualify if:

  • Previously underwent genetic testing for the condition of interest
  • Is incarcerated
  • Is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Related Publications (2)

  • Vassy JL, Brunette CA, Yi T, Assimes TL, Christensen KD, Knowles JW, Sturm AC, Sun YV, Alexander N, Cardellino MP, Harrison A, Gerety HL, Pyatt M, Vered R, Wilson PWF, Natarajan P, Whitbourne SB, Gaziano JM, Muralidhar S, Danowski ME; Veterans Affairs Million Veteran Program. Opportunistic Genomic Screening for Familial Hypercholesterolemia to Improve Low-Density Lipoprotein Cholesterol: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549664. doi: 10.1001/jamanetworkopen.2025.49664.

    PMID: 41511773DERIVED

  • Vassy JL, Brunette CA, Yi T, Harrison A, Cardellino MP, Assimes TL, Christensen KD, Devineni P, Gaziano JM, Gong X, Hui Q, Knowles JW, Muralidhar S, Natarajan P, Pyarajan S, Sears MG, Shi Y, Sturm AC, Whitbourne SB, Sun YV, Danowski ME; Million Veteran Program. Design and pilot results from the Million Veteran Program Return Of Actionable Results (MVP-ROAR) Study. Am Heart J. 2024 Oct;276:99-109. doi: 10.1016/j.ahj.2024.04.021. Epub 2024 May 17.

    PMID: 38762090DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

Limitations include: 1. Lower enrollment than planned 2. Baseline LDL-C values were carried forward for 15 participants missing their 6-month value 3. Participants with variants only detectable by sequencing were not included 4. LDL-C is a surrogate endpoint for long-term clinical outcomes

Results Point of Contact

Title
Morgan Danowski
Organization
VA Boston Healthcare System
morgan.danowski@va.gov
617-595-5385

Study Officials

  • Jason L Vassy, MD MPH

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 26, 2019

Study Start

February 27, 2020

Primary Completion

September 8, 2024

Study Completion

September 8, 2024

Last Updated

October 16, 2025

Results First Posted

October 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

We will share de-identified individual-level trial data through a data repository housed on a secure VA server and accessible only to outside investigators with IRB and other regulatory approvals. MVP ROAR Study data will also be stored in the VA MVP Central Database.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(1)