CommunicationPhase 3NCT07318363
IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention
A Phase 3 study testing IGNITE-TX program and Genetic Counseling and Testing in people with Communication and Informed Decision-making, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication, Informed Decision-making
- What is being tested?
- IGNITE-TX program and Genetic Counseling and Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Apr 2032
- Phase
- Phase 3
- 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
- Probands:
- 18 years of age or older
- Speaks and reads English or Spanish
- Resides in the United States
- Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2*
- Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number.
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- Attests to have at least one at-risk relative who meets inclusion criteria for first-degree relative
- For cancer patients who are unaware of their mutation status, we will share existing local and national genetics resources, like those provided in the usual care family letter.
- At-Risk Relatives (ARR):
- 18 years of age or older
- Speaks and reads English or Spanish
- Resides in the United States
- Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present
- Has access to internet or phone and can send and receive email and/or text messages at a US telephone number
- SAB:
- 1. Eligible SAB will include any groups connected to HBOC or Lynch syndrome, including those that focus on underserved populations or specific ethnic communities.
- Clinicians:
- 1. Eligible clinicians will include gynecologic oncologists, general gynecologists, medical oncologists, and advanced practice providers who interact with individuals diagnosed with HBOC or Lynch syndrome and/or their at-risk relatives.
Who cannot join
- Probands:
- Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information
- Has negative germline genetic testing or only variant of uncertain significance
- Unwilling or unable to provide consent
- At-Risk Relatives (ARR):
- Unwilling or unable to provide consent
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- Reports no known HBOC or LS variant within the family
- Has already been tested for the variant identified in the proband
- Already listed as an ARR for another proband
- SAB:
- 1. SAB members will be excluded if they are not connected to HBOC or Lynch syndrome-related groups or if their organizations do not focus on these conditions or the communities impacted by them.
- Clinicians:
- 1. Clinicians will be excluded if they do not provide direct care to individuals diagnosed with HBOC or Lynch syndrome or their at-risk relatives, or if they do not practice within the specified eligible clinician roles.
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
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
About this study
This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic testing/counseling.
Read the detailed description
Primary Objectives:
- Determine the impact of IGNITE-TX on the uptake of cascade genetic testing (CGT) in at-risk relatives (ARRs) at 6 months.
- Use a mixed methods approach, guided by the NIMHD framework, to evaluate the impact of IGNITE-TX on informational, social, and emotional support outcomes within families at 6 months.
- Employ formative and process evaluations and stakeholder engagement to guide IGNITE-TX implementation and dissemination through the RE-AIM QuEST framework.
Secondary Objective:
Analyze the correlation of CGT completion rates within families to understand the influence of familial relationships on genetic testing uptake.
Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.
Exploratory Objective:
Evaluate the effectiveness of social media as a mechanism to drive outreach, recruitment, and engagement with the IGNITE-TX intervention.
Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.
- Conditions
- Communication, Informed Decision-making
- Being tested
- IGNITE-TX program, Genetic Counseling and Testing
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGNITE-TX programOther
Participants will complete a questionnaire
Genetic Counseling and TestingOther
Participants will complete a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Experimental | ARRs: No active efforts will be made to ensure that ARRs complete genetic testing or to support family communication and education during the period in which primary study outcomes are being evaluated. Receives: Other: IGNITE-TX program; Other: Genetic Counseling and Testing |
| Free Genetic Counseling and Testing | Experimental | ARRs: A letter will be provided to the ARR with instructions on how to access genetic counseling and free testing through a telegenetics company (Appendix E). Receives: Other: IGNITE-TX program; Other: Genetic Counseling and Testing |
| IGNITE-TX Intervention | Experimental | ARRs: The relatives will receive instructions with a code to access the IGNITE-TX Hub (Appendix K \& L). Family Genetic Navigators will support this process by reaching out and guiding relatives through the process. Receives: Other: IGNITE-TX program; Other: Genetic Counseling and Testing |
| IGNITE-TX Intervention + Free Genetic Counseling and Testing | Experimental | ARRs: The relative will be sent instructions to access free counseling and testing, as well as a unique code to log into the IGNITE-TX Hub (Appendix K \& L). Family Genetic Navigators will support this process by reaching out and guiding relatives through both resources. Receives: Other: IGNITE-TX program; Other: Genetic Counseling and Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Alejandro Rauh-Hain, MD, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318363
- Sponsor's protocol ID
- 2025-1276
- Other IDs
- NCI-2025-09245
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention
- ClinicalTrials.gov ID
- NCT07318363
- Acronym / sponsor ID
- 2025-1276
- Conditions
- Communication, Informed Decision-making
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 6 Jan 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.
This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic testing/counseling.
Detailed description
Primary Objectives:
- Determine the impact of IGNITE-TX on the uptake of cascade genetic testing (CGT) in at-risk relatives (ARRs) at 6 months.
- Use a mixed methods approach, guided by the NIMHD framework, to evaluate the impact of IGNITE-TX on informational, social, and emotional support outcomes within families at 6 months.
- Employ formative and process evaluations and stakeholder engagement to guide IGNITE-TX implementation and dissemination through the RE-AIM QuEST framework.
Secondary Objective:
Analyze the correlation of CGT completion rates within families to understand the influence of familial relationships on genetic testing uptake.
Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.
Exploratory Objective:
Evaluate the effectiveness of social media as a mechanism to drive outreach, recruitment, and engagement with the IGNITE-TX intervention.
Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Experimental | Other: IGNITE-TX program, Other: Genetic Counseling and TestingARRs: No active efforts will be made to ensure that ARRs complete genetic testing or to support family communication and education during the period in which primary study outcomes are being evaluated. |
| Free Genetic Counseling and Testing | Experimental | Other: IGNITE-TX program, Other: Genetic Counseling and TestingARRs: A letter will be provided to the ARR with instructions on how to access genetic counseling and free testing through a telegenetics company (Appendix E). |
| IGNITE-TX Intervention | Experimental | Other: IGNITE-TX program, Other: Genetic Counseling and TestingARRs: The relatives will receive instructions with a code to access the IGNITE-TX Hub (Appendix K \& L). Family Genetic Navigators will support this process by reaching out and guiding relatives through the process. |
| IGNITE-TX Intervention + Free Genetic Counseling and Testing | Experimental | Other: IGNITE-TX program, Other: Genetic Counseling and TestingARRs: The relative will be sent instructions to access free counseling and testing, as well as a unique code to log into the IGNITE-TX Hub (Appendix K \& L). Family Genetic Navigators will support this process by reaching out and guiding relatives through both resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 years of age or older
- Speaks and reads English or Spanish
- Resides in the United States
- Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2*
- Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number.
Key exclusion criteria (13 listed)
- Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information
- Has negative germline genetic testing or only variant of uncertain significance
- Unwilling or unable to provide consent
- Unwilling or unable to provide consent
- Reports no known HBOC or LS variant within the family
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 |
|---|---|---|
| IGNITE-TX programParticipants will complete a questionnaire | Other | Free Genetic Counseling and Testing, IGNITE-TX Intervention, IGNITE-TX Intervention + Free Genetic Counseling and Testing, Standard of Care |
| Genetic Counseling and TestingParticipants will complete a questionnaire | Other | Free Genetic Counseling and Testing, IGNITE-TX Intervention, IGNITE-TX Intervention + Free Genetic Counseling and Testing, Standard of Care |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 17 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Jose Alejandro Rauh-Hain, MD, MPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IGNITE-TX program and Genetic Counseling and Testing in people with Communication and Informed Decision-making, run by M.D. Anderson Cancer Center 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 18 inclusion and 13 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 17 Jul 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jose Alejandro Rauh-Hain, MD, MPH ((713) 794-1759, jarauh@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 17 Jul 2026.