Gene Mutation-Related CancerNCT06089421
Genetic Information Assistant in Telegenetics
A study testing Genetic Information Assistant and Telegenetics with UVA genetic counselor in people with Gene Mutation-Related Cancer and Genetic Predisposition, run by University of Virginia at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is: Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gene Mutation-Related Cancer, Genetic Predisposition
- What is being tested?
- Genetic Information Assistant and Telegenetics with UVA genetic counselor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Aug 2027
- 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
- At high risk for having a genetic pathogenic variant as assessed by a GC or physician according to the NCCN guidelines
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 and over.
- Subjects must have a smartphone with access to cellular and/or internet service or a computer with internet service.
- Subjects must have technological competency/proficiency to use their Smartphone and/or computer in conjunction with the communication aid GIA.
Who cannot join
- Cannot communicate in English or Spanish.
- Subjects must not have completed panel-based cancer genetic testing in the past.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22930
Joseph Petruzziello
About this study
Official title: A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.
The goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is:
- Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing?
Read more
Participants will:
- have a pre-test genetic counselling session with a genetic counselor or the GIA chatbot
- answer questions about their cancer genetic knowledge and how they are doing
- provide a saliva sample for genetic testing to test for cancer gene mutations
- have their genetic testing results provided to them.
- have the option to share their genetic testing results with family members
Researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.
Read the detailed description
High risk patients will be randomized to standard of care telegenetics with a UVA Genetic Counselor (GC) for pre-test counseling or to the novel interventional arm of pre-test counseling via Genetic Information Assistant (GIA). Participants in the study will receive their link for a telegenetics appointment or GIA link based on randomization and patients will complete pre-test genetic counseling via their assigned treatment arm. Participants will not be masked to their trial arm assignment. In the telegenetics arm, patients will be offered a video visit scheduled through Epic zoom or a phone visit in our cancer genetics clinic per standard of care. Patients randomized to the GIA arm will receive a personalized link based on their family history. At the completion of counseling, participants will be offered genetic testing. If they agree, they will be mailed a saliva kit via Invitae Genetics for panel based genetic testing via The Invitae Common Hereditary Cancers panel to analyze 47 genes associated with cancers of the breast, ovary, uterus, and gastrointestinal system, which includes the stomach, colon, rectum, small bowel, and pancreas.
- Being tested
- Genetic Information Assistant, Telegenetics with UVA genetic counselor
- 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.
Genetic Information AssistantOther
Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling.
Telegenetics with UVA genetic counselorOther
Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care telegenetics with a UVA genetic counselor (GC) for pre-test counseling | Active comparator | Pre-genetic test counselling with a genetic counselor from the University of Virginia Receives: Other: Telegenetics with UVA genetic counselor |
| Novel interventional arm of pre-test counseling via GIA | Experimental | Pre-genetic test counselling through novel chat bot Genetic Information Assistant (GIA) Receives: Other: Genetic Information Assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC
dichotomous measurement of whether the randomized participant completes genetic testing within three months.
Measured: 3 months
Secondary outcomes (5)
To test cancer knowledge following the pre-test genetic counseling with GIA versus GC
National Center for Human Genome Research Knowledge scale taken at baseline and one month after genetic testing.
Measured: 3 months
To assess differences of Comprehensive Score of Financial Toxicity scale
To assess the difference in comprehensive score between one- and six-months of Comprehensive Score for Financial Toxicity (COST) survey. Scoring: 0 (Poor Financial well-being) to 48 (Better financial well-being)
Measured: 6 months
To assess differences of SURE scale
To assess the difference in comprehensive scores of the following surveys between one- and six-months of SURE scale. Scoring 0-4: Score <4 is a positive result for decisional conflict.
Measured: 6 months
To assess differences of Decisional Conflict scale
To assess the difference in comprehensive scores of the following surveys between one- and six-months Decisional Conflict Scale. Scoring: 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Measured: 6 months
To assess differences of Multi-dimensional Impact of Cancer Risk Assessment (MICRA) scale
To assess the difference in comprehensive scores of the following surveys between one- and six-months Multi-dimensional Impact of Cancer Risk Assessment (MICRA) survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Apr 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene Mutation-Related CancerStudies of the same condition, open and under way.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Ring, MD, University of Virginia
- Investigators
- Kari Ring, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089421
- Sponsor's protocol ID
- HSR230209
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2023
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial to Compare Telegenetics to Counseling Via a Novel Genetic Information Assistant in High-risk Cancer Patients.
- ClinicalTrials.gov ID
- NCT06089421
- Acronym / sponsor ID
- HSR230209
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Oct 2023 (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 about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is:
- Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing?
Participants will:
- have a pre-test genetic counselling session with a genetic counselor or the GIA chatbot
- answer questions about their cancer genetic knowledge and how they are doing
- provide a saliva sample for genetic testing to test for cancer gene mutations
- have their genetic testing results provided to them.
- have the option to share their genetic testing results with family members
Researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.
Detailed description
High risk patients will be randomized to standard of care telegenetics with a UVA Genetic Counselor (GC) for pre-test counseling or to the novel interventional arm of pre-test counseling via Genetic Information Assistant (GIA). Participants in the study will receive their link for a telegenetics appointment or GIA link based on randomization and patients will complete pre-test genetic counseling via their assigned treatment arm. Participants will not be masked to their trial arm assignment. In the telegenetics arm, patients will be offered a video visit scheduled through Epic zoom or a phone visit in our cancer genetics clinic per standard of care. Patients randomized to the GIA arm will receive a personalized link based on their family history. At the completion of counseling, participants will be offered genetic testing. If they agree, they will be mailed a saliva kit via Invitae Genetics for panel based genetic testing via The Invitae Common Hereditary Cancers panel to analyze 47 genes associated with cancers of the breast, ovary, uterus, and gastrointestinal system, which includes the stomach, colon, rectum, small bowel, and pancreas.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care telegenetics with a UVA genetic counselor (GC) for pre-test counseling | Active comparator | Other: Telegenetics with UVA genetic counselorPre-genetic test counselling with a genetic counselor from the University of Virginia |
| Novel interventional arm of pre-test counseling via GIA | Experimental | Other: Genetic Information AssistantPre-genetic test counselling through novel chat bot Genetic Information Assistant (GIA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At high risk for having a genetic pathogenic variant as assessed by a GC or physician according to the NCCN guidelines
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 and over.
- Subjects must have a smartphone with access to cellular and/or internet service or a computer with internet service.
Key exclusion criteria (2 listed)
- Cannot communicate in English or Spanish.
- Subjects must not have completed panel-based cancer genetic testing in the past.
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 |
|---|---|---|
| Genetic Information AssistantParticipants assigned will receive a link to Genetic Information Assistant for pre-test counseling. | Other | Novel interventional arm of pre-test counseling via GIA |
| Telegenetics with UVA genetic counselorParticipants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor. | Other | Standard of care telegenetics with a UVA genetic counselor (GC) for pre-test counseling |
Primary outcome
To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC
Time frame: 3 months
dichotomous measurement of whether the randomized participant completes genetic testing within three months.
5 secondary outcomes
To test cancer knowledge following the pre-test genetic counseling with GIA versus GC
Time frame: 3 months
To assess differences of Comprehensive Score of Financial Toxicity scale
Time frame: 6 months
To assess differences of SURE scale
Time frame: 6 months
To assess differences of Decisional Conflict scale
Time frame: 6 months
To assess differences of Multi-dimensional Impact of Cancer Risk Assessment (MICRA) scale
Time frame: 6 months
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 23 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Gene Mutation-Related Cancer
Active, not recruitingObservational study
Distribution of the Homologous Recombination-related (HRR) Genesmutationsand HRD in Breast Cancer
Breast Cancer, HER2-low Breast Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Active, not recruitingPhase 2
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
Metastatic Triple Negative Breast Cancer
RecruitingPhase 1/2
Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
Non-small Cell Lung Cancer, Histiocytic Neoplasm
RecruitingPhase 1
XL092 and Cemiplimab in BRAF WT Thyroid Cancer
Anaplastic Thyroid Cancer, Thyroid Cancer
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.
Kari Ring, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Information Assistant and Telegenetics with UVA genetic counselor in people with Gene Mutation-Related Cancer and Genetic Predisposition, run by University of Virginia at 1 site in United States.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Sep 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 United States. 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?
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 Evelyn Villalobos ((434) 297-4579, EV4PD@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC (time frame: 3 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 23 Sep 2025.