Clinical Trial

"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"

Study acronym: GIM29-GIMOMIC
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Record status
This record was last updated March 13, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.
Summary
The study aims to establish an Italian registry for the implementation of the use of genomic tests in patients with HR +/HER2- breast cancer at intermediate risk of recurrence after the entry into force of the Ministerial Decree of 18/05/2021. The decree has established the reimbursability of genomic testing for breast cancer patients, thereby influencing clinical decision-making and patient management within Breast Units. In addition, the study aims to evaluate the clinical impact of the use of genomic testing on the type of adjuvant treatment, in terms of change of treatment indication by breast units according to the test result.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-06.
Trial Details
NCT Number NCT06871501
Lead Sponsor Consorzio Oncotech
Conditions Breast Cancer
Enrollment 1,000 participants
Start Date 2025-03
Primary Completion 2025-05 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2025-03-13