Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
Running, not enrolling · Not applicable
Conditions studied: Gynecologic Cancer, Ovary Cancer, Pancreatic Cancer, Breast Cancer, Lynch Syndrome, Hereditary Breast and Ovarian Cancer Syndrome, Colon Cancer, Endometrial Cancer, Uterus Cancer
In brief
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.
Key facts
- Study ID
- NCT05677048
- Run by
- M.D. Anderson Cancer Center
- People needed
- 205
- Starts
- 2023-04-14
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
- Inclusion Criteria:
- 18 years of age or older
- 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
- Exclusion Criteria:
- 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
Where it is running
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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