ClinicalTrials.gg
Not yet recruitingNCT07318363Updated Jul 17, 2026

IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention

A Phase 3 interventional study of IGNITE-TX program and Genetic Counseling and Testing in Communication and Informed Decision-making, sponsored by M.D. Anderson Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
2,100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 testing/counseling.

Read the detailed description

Primary Objectives:

  1. Determine the impact of IGNITE-TX on the uptake of cascade genetic testing (CGT) in at-risk relatives (ARRs) at 6 months.
  2. 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.
  3. 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.

02

Conditions studied

  • Communication
  • Informed Decision-making

Browse trials for

03

In context

Communication

719 studies on the registry are indexed under Communication; 159 are open to participants now.

This study's planned enrollment of 2,100 is above the median of 144 across 571 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Probands:

  1. 18 years of age or older
  2. Speaks and reads English or Spanish
  3. Resides in the United States
  4. Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2*
  5. Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number.
  6. 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):

  1. 18 years of age or older
  2. Speaks and reads English or Spanish
  3. Resides in the United States
  4. Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present
  5. 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.

Exclusion criteria

Exclusion Criteria:

Probands:

  1. Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information
  2. Has negative germline genetic testing or only variant of uncertain significance
  3. Unwilling or unable to provide consent

At-Risk Relatives (ARR):

  1. Unwilling or unable to provide consent
  2. Reports no known HBOC or LS variant within the family
  3. Has already been tested for the variant identified in the proband
  4. 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.

05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2,100 participants (estimated)

Study arms

  • Experimental
    Standard of Care

    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.

    Other: IGNITE-TX program · Other: Genetic Counseling and Testing

  • Experimental
    Free Genetic Counseling and Testing

    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).

    Other: IGNITE-TX program · Other: Genetic Counseling and Testing

  • Experimental
    IGNITE-TX Intervention

    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.

    Other: IGNITE-TX program · Other: Genetic Counseling and Testing

  • Experimental
    IGNITE-TX Intervention + Free Genetic Counseling and Testing

    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.

    Other: IGNITE-TX program · Other: Genetic Counseling and Testing

Interventions

  • OtherIGNITE-TX program

    Participants will complete a questionnaire

  • OtherGenetic Counseling and Testing

    Participants will complete a questionnaire

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion; an average of 1 year

07

Study locations

1 site
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07318363
Responsible party
Sponsor
First posted
Jan 6, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Apr 1, 2030 (estimated)
Completion
Apr 1, 2032 (estimated)
Last update
Jul 17, 2026

Study contacts

Jose Alejandro Rauh-Hain, MD, MPH
Contact
jarauh@mdanderson.org
(713) 794-1759
Jose Alejandro Rauh-Hain, MD, MPH
principal investigator · M.D. Anderson Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion