Genetic PredispositionPROACTNCT07478237
The Preventive Risk Outreach And Cascade Testing
A study testing Minimally facilitated platform and AI-powered platform in people with Genetic Predisposition and Family Members, run by Stanford University.
Trial summary
The goal of this clinical trial is to learn whether a new online program developed by the research team is able to help families learn about family cancer risk and how to reduce this risk, as well as help interested family members get low-cost, at-home genetic testing for cancer risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition, Family Members
- What is being tested?
- Minimally facilitated platform and AI-powered platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Known to carry a pathogenic or likely pathogenic variant in a gene included in the 2024 current Color Health Cancer Panel Test.
- Have at least one (1) first- or second-degree relative who is living in the United States and has not yet had germline genetic testing.
- Age ≥ 18 years old.
- Resides in the United States.
Who cannot join
- 1. Unable to read and write English or Spanish.
- Completed genetic testing by a clinician within the last 5 years that included the pathogenic or likely pathogenic variant.
- Not a first- or second-degree relative of the proband.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Preventive Risk Outreach and Cascade Testing (PROACT)
The goal of this clinical trial is to learn whether a new online program developed by the research team is able to help families learn about family cancer risk and how to reduce this risk, as well as help interested family members get low-cost, at-home genetic testing for cancer risk.
Read the detailed description
The overarching goal of this study is to facilitate cascade genetic testing to reduce the burden of cancer in families with hereditary cancer syndromes (HCS). We will evaluate different versions of a point-of-care cascade genetic testing referral service for probands with recently detected pathogenic or likely pathogenic genetic variants.
- Conditions
- Genetic Predisposition, Family Members
- Being tested
- Minimally facilitated platform, AI-powered platform
- Keywords
- Cascade genetic testing
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally facilitated platformOther
This group will receive access to low-cost genetic testing via an email link and an access code.
AI-powered platformOther
This group will receive access to low-cost genetic testing via an AI-powered platform that will also provide genetic education, motivational interviewing, and family communication
| Study group | Role | What they receive |
|---|---|---|
| PROACT Platform - Minimally Facilitated Testing | Experimental | The Minimally Facilitated testing arm is a simplified version of the PROACT-AI platform, that provides participants with access to low-cost testing only, in addition to standard of care. Receives: Other: Minimally facilitated platform |
| PROACT Platform - AI | Experimental | The AI-powered arm will provide participants access to low-cost testing via an AI-powered platform as well as provide additional features including genetic education, motivational interviewing, family communication, and complete follow-up surveys. Receives: Other: AI-powered platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm
Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm
Measured: 6 months
Secondary outcomes (5)
Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm
Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm
Measured: 6 months
Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm
Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm
Measured: 6 months
Proportion of eligible relatives invited by the patient in each study arm
Proportion of eligible relatives invited by the patient in each study arm
Measured: 180 days
Proportion of eligible relatives who join the PROACT program in each study arm
Proportion of eligible relatives who join the PROACT program in each study arm
Measured: 28 days
Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only]
Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only]
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Jennifer Lee Caswell-Jin, Stanford University
- Investigators
- Allison Kurian, MD, Principal investigator, Stanford UniversityJennifer Lee Caswell-Jin, MD, Principal investigator, Stanford UniversitySteven Katz, MD, Principal investigator, University of MichiganLawrence An, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478237
- Sponsor's protocol ID
- 82980
- Acronym
- PROACT
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Risk Outreach and Cascade Testing (PROACT)
- ClinicalTrials.gov ID
- NCT07478237
- Acronym / sponsor ID
- PROACT / 82980
- Conditions
- Genetic Predisposition, Family Members
- Keywords
- Cascade genetic testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Mar 2026 (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 goal of this clinical trial is to learn whether a new online program developed by the research team is able to help families learn about family cancer risk and how to reduce this risk, as well as help interested family members get low-cost, at-home genetic testing for cancer risk.
Detailed description
The overarching goal of this study is to facilitate cascade genetic testing to reduce the burden of cancer in families with hereditary cancer syndromes (HCS). We will evaluate different versions of a point-of-care cascade genetic testing referral service for probands with recently detected pathogenic or likely pathogenic genetic variants.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROACT Platform - Minimally Facilitated Testing | Experimental | Other: Minimally facilitated platformThe Minimally Facilitated testing arm is a simplified version of the PROACT-AI platform, that provides participants with access to low-cost testing only, in addition to standard of care. |
| PROACT Platform - AI | Experimental | Other: AI-powered platformThe AI-powered arm will provide participants access to low-cost testing via an AI-powered platform as well as provide additional features including genetic education, motivational interviewing, family communication, and complete follow-up surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Known to carry a pathogenic or likely pathogenic variant in a gene included in the 2024 current Color Health Cancer Panel Test.
- Have at least one (1) first- or second-degree relative who is living in the United States and has not yet had germline genetic testing.
- Age ≥ 18 years old.
- Resides in the United States.
Key exclusion criteria (3 listed)
- 1. Unable to read and write English or Spanish.
- Completed genetic testing by a clinician within the last 5 years that included the pathogenic or likely pathogenic variant.
- Not a first- or second-degree relative of the proband.
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 |
|---|---|---|
| Minimally facilitated platformThis group will receive access to low-cost genetic testing via an email link and an access code. | Other | PROACT Platform - Minimally Facilitated Testing |
| AI-powered platformThis group will receive access to low-cost genetic testing via an AI-powered platform that will also provide genetic education, motivational interviewing, and family communication | Other | PROACT Platform - AI |
Primary outcome
Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm
Time frame: 6 months
Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm
5 secondary outcomes
Proportion of eligible first-degree relatives who undergo genetic testing through Color Health in each study arm
Time frame: 6 months
Proportion of index patients for whom at least one eligible relative undergoes genetic testing through Color Health in each study arm
Time frame: 6 months
Proportion of eligible relatives invited by the patient in each study arm
Time frame: 180 days
Proportion of eligible relatives who join the PROACT program in each study arm
Time frame: 28 days
Proportion of relatives who completed the genetic risk education modules as measured by platform paradata [PROACT platform-AI Arm Only]
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- 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.
Allison Kurian, MD principal investigator
Stanford University
Jennifer Lee Caswell-Jin, MD principal investigator
Stanford University
Steven Katz, MD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Minimally facilitated platform and AI-powered platform in people with Genetic Predisposition and Family Members, run by Stanford University.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonia Rios-Ventura (6507258762, proactprogram@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of all eligible first- and second-degree relatives who undergo genetic testing through Color Health in each study arm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.