Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
Recruiting
Observational Study
Breast Cancer
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 234 (estimated)
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna · Other
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About This Trial
The goal of the retrospective phase of this study is to validate the specificity and the sensitivity of two Real-Time quantitative PCR based techniques in order to support the gold-standard approaches used to evaluate the HER2 gene status in breast cancer.
Furthemore, HER2-low patients are enrolled in a prospective phase, both in early stage and in case of recurrence, in order to monitorate HER2 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Histologic confirmation of breast cancer from 1/1/2022
* Patient treated with systemic and surgical therapy (retrospective phase)
* Signed informed consent
* HER2-0 and/or HER2-low patient, according to IHC and D-DISH/FISH, treatable with systemic and surgical …
Contacts