NCT06813456 Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype
| NCT ID | NCT06813456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 234 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 234 participants in total. It began in 2024-11-08 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 therapy (prospective phase) Exclusion Criteria: * 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)
Contact & Investigator
Sara Coluccelli, PhD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06813456 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06813456 currently recruiting?
Yes, NCT06813456 is actively recruiting participants. Contact the research team at sara.coluccelli@aosp.bo.it for enrollment information.
Where is the NCT06813456 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06813456 clinical trial?
NCT06813456 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Sara Coluccelli, PhD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 234 participants.
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