Clinical trial · Interventional
The Genetic Information and Family Testing (GIFT) Study
NCT05552664CI-TRIAL-00101594GIFTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Genetic Information and Family Testing (GIFT) Study is designed to support the capacity, opportunity, and motivation of cancer patients to engage their relatives about inherited cancer susceptibility and provide support and services to those relatives to initiate GRE (including genetic testing) and prepare them to subsequently engage their clinicians in informed decision-making about cancer prevention and early detection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GIFT | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Arm 1
- description
- Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
- interventionNames
- Genetic: GIFT
- type
- OTHER
- label
- Arm 2
- description
- Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.
- interventionNames
- Genetic: GIFT
- type
- OTHER
- label
- Arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria for the PICS survey are: 1. diagnosed with any cancer at any stage in 2018-2019 and reported to the Georgia or California SEER registries 2. Been found to carry a pathogenic variant (PV) in one of 27 cancer susceptibility genes (see Table 4) according to the Georgia California Genetic Testing Linkage Initiative dataset 3. aged 18 or older 4. alive at the time of selection as determined through linkage with Georgia and California vital statistics data. Additional eligibility criteria for Patient Trial Invitation will be evaluated from patient response to the PICS survey and will include patient report of: 1. Receipt of genetic testing for cancer risk 2. A positive test result (pathogenic variant; PV) Inclusion criteria for Relative Trial Invitation are assessed via patient report: 1. first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relative of a patient enrolled in the study; 2. aged 18 or older; 3. alive at the time of study invitation; 4. relative lives in the United States or Canada (countries in which Color genetic testing is available, most people speak either English or Spanish, and test kit shipping costs are not exorbitant) Additional eligibility criteria for Relative Trial Enrollment will be evaluated from relative response to the relative eligibility screening survey (see Appendix C) and will include: 1. confirmation from the relative that they have not received clinical genetic testing ordered by a doctor or genetic counselor within the past five years (proxy for having already been tested for the PV carried by the patient who invited them into the study); 2. confirmation of age 18 or older; 3. confirmation of first-degree (biological parent, sibling, or biological child) or second-degree (biological half-sibling, aunt, uncle, nephew, niece, grandparent, or grandchild) relation to the patient. 4. confirmation of residence in United States or Canada Exclusion Criteria Exclusion criteria for the PICS survey are: 1\) Age\<18 Additional exclusion criteria for Patient Trial Invitation: 1. Patients who do not report receipt of genetic testing 2. Patients who do not report a positive genetic test result (PV) Exclusion criteria for Relative Trial Invitation are: 1. Age\<18 2. Relative does not live in the United States or Canada Additional exclusion criteria for Relative Trial Enrollment include relative report of: 1. Age\<18; 2. Receipt of genetic testing ordered by a doctor or genetic counselor within the past five years; 3. Relationship to proband (inviting) patient other than first- or second-degree relative 4. Residence in a country other than United States or Canada
References
Publications (2)
- DERIVEDKatz SJ, Hofer TP, Abrahamse P, Courser RR, Hodan R, Tocco RS, Rios-Ventura S, Ward KC, Hamilton AS, Frey MK, An LC, Kurian AW. Results From the Genetic Information and Family Testing Study: A Cluster-Randomized Trial. J Clin Oncol. 2026 May;44(13):1216-1224. doi: 10.1200/JCO-25-02196. Epub 2026 Mar 24. PMID 41875376
- DERIVEDKatz SJ, Abrahamse P, Hofer TP, Courser RR, Hodan R, Tocco RS, Rios-Ventura S, Ward KC, Hamilton AS, Kurian AW, An LC. The Genetic Information and Family Testing (GIFT) study: trial design and protocol. BMC Cancer. 2025 Feb 27;25(1):366. doi: 10.1186/s12885-025-13744-6. PMID 40016666