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Active, not recruitingNCT05677048Updated Sep 16, 2026

Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention

An interventional study of Free genetic testing and counseling group and IGNITE-TX Group in Gynecologic Cancer, Ovary Cancer and Pancreatic Cancer, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
205
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a community-based study requiring participant-self-enrollment, that can help to increase the rates of genetic testing among the family members of people who have been diagnosed with a hereditary cancer syndrome. The two main factors in this study are the IGNITE-TX intervention (website and navigator) and the free genetic counseling and testing.

The IGNITE-TX Intervention is an innovative multi-modal intervention, with two components: a) interactive web "IGNITE-TX Hub" and b) genetic family navigators.

Read the detailed description

Primary Objectives:

The primary objectives of this study are to assess the study feasibility by estimating:

  1. The enrollment of probands and (ARRs) at-risk relatives over a 6-month period
  2. The response rate to baseline and follow-up surveys by probands
  3. The response rate to baseline and follow-up surveys by (ARRs) at-risk relatives

Secondary Objectives:

The secondary objectives of this study are to:

  1. Measure (ARR) at-risk relatives completion of (CGT) cascade genetic testing among different study arms.
  2. Measure the proportion of enrolled (ARRs) at-risk relatives who make an informed decision about (CGT) cascade genetic testing.
  3. Measure the (ARR) at-risk relatives readiness for (CGT) cascade genetic testing
  4. Measure proband and (ARR) at-risk relatives change in genetics knowledge
  5. Measure proband readiness to communicate results of genetic testing with (ARR) at-risk relatives Secondary objectives in this feasibility study will be primary objectives in a larger study. This feasibility study is not powered to assess these objectives. Including them in this feasibility study will allow for assessment of our measurement tools (surveys from primary objectives) and offer insight into how the intervention may impact cascade genetic testing when implemented on a larger scale

Exploratory Objectives:

The exploratory objectives in this study are to estimate:

  1. The average website traffic of the IGNITE-TX "Hub" and module completion
  2. The average utilization of family genetic navigators by participants
  3. Estimate the intra-familial correlation (IFC) for (ARR) at-risk relatives completion of (CGT) cascade genetic testing
  4. Assess satisfaction with IGNITE-TX website modules and genetic navigator The exploratory objectives will allow for further evaluation of the IGNITE-TX website modules and navigator and understand how families with multiple (ARR)at-risk relatives respond to the intervention.
02

Conditions studied

  • Gynecologic Cancer
  • Ovary Cancer
  • Pancreatic Cancer
  • Breast Cancer
  • Lynch Syndrome
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Colon Cancer
  • Endometrial Cancer
  • Uterus Cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 205 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (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
No

Eligibility criteria

Probands

Inclusion Criteria:

  1. 18 years of age or older
  2. Speaks and/or reads English or Spanish
  3. Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS)
  4. Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number
  5. Has at least one at-risk relative who meets inclusion criteria for first-degree relative

Exclusion Criteria:

  1. Has no at-risk relatives meeting inclusion criteria
  2. Has negative germline genetic testing or only variant of uncertain significance
  3. Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR)

Inclusion Criteria:

  1. 18 years of age or older
  2. Speaks and reads English or Spanish
  3. Resides in the United States
  4. Can provide proof of deleterious/suspected deleterious HBOC or LS variant present in a first degree relative (biological mother or father, biological child, or full sibling)
  5. Has access to internet or phone and can send and receive email and/or text messages at a US telephone number

Exclusion Criteria:

  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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
205 participants (actual)

Study arms

  • No intervention
    Group 1 (Standard of Care Group)

    Participants (probands, those with a hereditary cancer syndrome) are sent a family letter to share with relatives. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing. Relatives of probands randomized to the usual care arm will have access to the family letter if probands decide to share it with them, and will receive study surveys. The letter contains information about hereditary cancer syndromes and encourages relatives to participate in the study and to get genetic testing

  • Experimental
    Group 2 (Free genetic testing and counseling group)

    Enrolled relatives will receive a letter and baseline survey with information to contact the tele-genetics company to arrange free genetic counseling and testing. This letter will be given to the relatives directly by the study

    Behavioral: Free genetic testing and counseling group · Behavioral: IGNITE-TX Group · Behavioral: IGNITE-TX and free genetic testing and counseling group

  • Experimental
    Group 3 (IGNITE-TX Group)

    Relatives of probands randomized to the IGNITE-TX intervention will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform). Relatives will have also access services of a family genetic navigator. Study investigators and navigators will not directly provide genetic counseling and/or testing in this arm

    Behavioral: Free genetic testing and counseling group · Behavioral: IGNITE-TX Group · Behavioral: IGNITE-TX and free genetic testing and counseling group

  • Experimental
    Group 4 (IGNITE-TX and free genetic testing and counseling group)

    Relatives randomized to this arm will receive a family letter after enrollment and baseline survey with their personal access codes (not to be shared) to the IGNITE-TX "Hub" (access online educational material through a platform) and information to contact the tele genetics company. This arm will receive both the IGNITE-TX Intervention and access to free genetic testing and counseling services, as well as access to assistance from family genetic navigator

    Behavioral: Free genetic testing and counseling group · Behavioral: IGNITE-TX Group · Behavioral: IGNITE-TX and free genetic testing and counseling group

Interventions

  • BehavioralFree genetic testing and counseling group

    Option to access no-cost telegenetic counseling and genetic testing

  • BehavioralIGNITE-TX Group

    Access online educational materials through the IGNITE-TX platform and receive assistance from a family genetic navigator

  • BehavioralIGNITE-TX and free genetic testing and counseling group

    Option to access no-cost telegenetic counseling and genetic testing, access to online educational materials through the IGNITE-TX platform, and assistance from a family genetic navigator

06

What researchers measure

Primary outcomes

  1. Measure enrollment of probands and at-risk relatives over a 6-month period

    Time frame: Up to 6 months

  2. Measure response rate to baseline and follow-up surveys by probands and at-risk relatives

    Time frame: Up to 6 months

07

Study locations

1 site
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Jorgensen KA, Agusti N, Coffin T, Barajas K, Iniesta MD, Bednar EM, Kanbergs A, Wilke RN, Beshar I, Pirzadeh-Miller S, Lahiri S, Pratt K, Jennings K, Bosch H, Leath CA 3rd, Karlan B, Frey M, Sharaf R, Lu K, Rauh-Hain JA. A Multilevel Intervention to Identify Individuals for Genetic Testing and Treatment: The IGNITE-TX Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2630668. doi: 10.1001/jamanetworkopen.2026.30668. PubMed 42658496 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05677048
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jan 10, 2023
Start date
Apr 14, 2023
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Jose Rauh-Hain, MD,MPH
principal investigator · M.D. Anderson Cancer Center

Oversight

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

Not currently enrolling

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

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