IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
Recruiting · NCT06703567 · Interventional (participants receive a specific treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Standard PolicyStandard Policy + GEP Information Film
What this trial is about
The primary aim of the study is to determine if provision of a patient information film about Oncotype DX improves patients' knowledge and understanding about Gene Expression Profiling (GEP) test and risk of recurrence results in early breast cancer (EBC) patients, identified by their clinical teams as potentially benefiting from having their tumor samples sent for GEP analysis.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- First presentation of early stage breast cancer with all known disease surgically removed
- Estrogen Receptor (ER) positive and Human Epidermal growth factor Receptor 2 (HER-2) negative
- No clear decision on whether chemotherapy should be given as adjunct based on current prognostic criteria
- Consented to GEP testing
- Able to give full informed consent to IMPARTER study
- Good comprehension of the Italian language
- Access to internet connection and devices (e.g. smart phone, tablet, laptop or desktop computer)
Exclusion criteria
- Other breast cancer diagnosis (e.g. Ductal carcinoma in situ, Metastatic)
- Unable to give fully informed consent
- Under 18 years of age
- Unable to understand and speak Italian
- No access to internet connection or devices
Where it is running
1 location listed.
- European Institute of Oncology - Milan, Italy