Actively Recruiting
Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-07
234
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 expression levels changes under treatments by using liquid biopsy. The first aim is to be able to distinguish responders vs non-responders earlier than the standard monitoring through tumoral markers and medical examination.
CONDITIONS
Official Title
Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �38 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 therapy (prospective phase)
You will not qualify if you...
- Lack of molecular classification on the basis of prognostic-predictive markers ER, PR, Ki67 and HER2 (Luminal A, Luminal B HER2-positive, Luminal B HER2- negative, HER2-positive, Triple negative)
- Prior neoplasms, other than the neoplasm under investigation, arised within the past 5 years
- Missing histological diagnosis of HER2-0 and/or HER2-low breast cancer (prospective phase)
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
S
Sara Coluccelli, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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