Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT05203458
Eligibility Criteria:
Inclusion Criteria:
Patients fulfilling all of the following criteria will be eligible for this study:
* Male and female patients must have a histological confirmed diagnosis of BC
* The patients must be ≥18 years old at the diagnosis.
* In PART 1, all patients should be diagnosed at FUSCC between Jan 2015 and Dec 2015.
* In PART 2, all patients should be diagnosed at all participating sites between July 2021 and July 2022.
* Provision of at least 1 archived HER2 IHC slides associated with confirmed diagnosis of BC, which are in good condition for rescoring.
* FISH result is available for HER2 IHC2+ in primary scoring.
Exclusion Criteria:
Patients who meet any of the following criteria will be disqualified from entering the study:
* Absence of all demographic, histopathologic, clinicopathologic information .
* Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05203458
Study Brief:
Protocol Section:
NCT05203458