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Can a toolkit expand access to genomic screening?

NCT ID NCT07806643

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether a guide called the FOCUS toolkit helps healthcare sites run population-wide genomic screening programs more effectively. Researchers will compare sites that use the toolkit with those that do not, measuring how many people take part and how well the programs are adopted and maintained. The study does not change individual patient care; it focuses on improving how screening programs are implemented.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FOCUS Toolkit, a multicomponent implementation guide for population-wide genomic screening programs
What this could lead to
If the toolkit works, it could help more healthcare systems adopt genomic screening, potentially catching more genetic risks early.
What could go wrong
The trial is small and focuses on how programs run, not on direct health outcomes. Results may not apply to all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will include specific sites population genomic screening (PGS) rather than individual participants.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Operate an active or population genomic screening (PGS) program. * Agree to utilize the FOCUS Toolkit throughout the trial and engage staff in its use and fidelity tracking. * Ability to understand and willingness to sign a data use agreement and comply with study procedures for the entire length of the study. * Ability to provide program-level data (Reach, Effectiveness, Adoption, Implementation, Maintenance) quarterly. * Confirmation of implementing or sustaining stage, as determined by the investigator. * Capacity to participate in stakeholder surveys and interviews at study conclusion. * Ability to read and understand the English language. Exclusion Criteria: * They lack infrastructure to collect and share required data. * They cannot commit to toolkit use or quarterly reporting. * They are unable to comply with study timelines

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Population genomic screening implementation best practices

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Memorial Hermann-Texas Medical Center

    Houston, Texas, 77030, United States

  • Moses Cone Hospital

    Greensboro, North Carolina, 27401, United States

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania, 18015, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • WellSpan York Hospital

    York, Pennsylvania, 17403, United States