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Recruiting Not applicable

IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4

NCT06703567 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-09-06
Last updated
2024-12-10

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Standard PolicyStandard Policy + GEP Information Film

Standard Policy: Patients will receive information about the GEP test by clinical teams

Standard Policy + GEP Information Film: Patients will receive information about the GEP test by clinical teams and, after consultation with physician, they will be sent a link to view the film regarding OncotypeDX

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • GEP Knowledge Evaluation — 1 week
    Collection of Gene Expression Profiling (GEP) Knowledge Questionnaire (higher total score indicates better understanding)

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06703567 on ClinicalTrials.gov ↗ ← All trials in Italy