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AzTrials

Gynecologic CancerNCT05677048

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

A study testing Free genetic testing and counseling group, IGNITE-TX Group and IGNITE-TX and free genetic testing and counseling group in people with Gynecologic Cancer and Ovary Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Free genetic testing and counseling group, IGNITE-TX Group and IGNITE-TX and free genetic testing and counseling group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
1 siteUnited States
Study dates
14 Apr 2023to 31 Oct 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Speaks and/or reads English or Spanish
  • Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS)
  • Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number
  • Has at least one at-risk relative who meets inclusion criteria for first-degree relative
  • 18 years of age or older
Show all 10Show fewer
  • Speaks and reads English or Spanish
  • Resides in the United States
  • 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)
  • Has access to internet or phone and can send and receive email and/or text messages at a US telephone number

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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.
Being tested
Free genetic testing and counseling group, IGNITE-TX Group, IGNITE-TX and free genetic testing and counseling group
Medical subject headings
Ovarian Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary Breast and Ovarian Cancer Syndrome, Colonic Neoplasms, Endometrial Neoplasms, Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Free genetic testing and counseling groupBehavioural

    Option to access no-cost telegenetic counseling and genetic testing

  • IGNITE-TX GroupBehavioural

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

  • IGNITE-TX and free genetic testing and counseling groupBehavioural

    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

Study groups in NCT05677048
Study groupRoleWhat they receive
Group 1 (Standard of Care Group)No interventionParticipants (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
Group 2 (Free genetic testing and counseling group)ExperimentalEnrolled 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
Receives: Behavioral: Free genetic testing and counseling group; Behavioral: IGNITE-TX Group; Behavioral: IGNITE-TX and free genetic testing and counseling group
Group 3 (IGNITE-TX Group)ExperimentalRelatives 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
Receives: Behavioral: Free genetic testing and counseling group; Behavioral: IGNITE-TX Group; Behavioral: IGNITE-TX and free genetic testing and counseling group
Group 4 (IGNITE-TX and free genetic testing and counseling group)ExperimentalRelatives 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
Receives: Behavioral: Free genetic testing and counseling group; Behavioral: IGNITE-TX Group; Behavioral: IGNITE-TX and free genetic testing and counseling group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 6 months

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

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2023
  2. Study start14 Apr 2023
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05677048
Sponsor's protocol ID
2022-0712
Other IDs
FP00015533, NCI-2022-10573
Status last verified
Sep 2026
First submitted
14 Dec 2022
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Free genetic testing and counseling group, IGNITE-TX Group and IGNITE-TX and free genetic testing and counseling group in people with Gynecologic Cancer and Ovary Cancer, 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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure enrollment of probands and at-risk relatives over a 6-month period (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677048, which also lists 1 linked publication.

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 16 Sep 2026.

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