Clinical trial · Interventional
Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
| Ovary Cancer | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Uterus Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Free genetic testing and counseling group | Behavioral | — | UNRESOLVED |
| IGNITE-TX and free genetic testing and counseling group | Behavioral | — | UNRESOLVED |
| IGNITE-TX Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Group 1 (Standard of Care Group)
- description
- 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
- type
- EXPERIMENTAL
- label
- Group 2 (Free genetic testing and counseling group)
- description
- 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
- interventionNames
- Behavioral: Free genetic testing and counseling group
- Behavioral: IGNITE-TX Group
- Behavioral: IGNITE-TX and free genetic testing and counseling group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJorgensen 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. PMID 42658496