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Implementation of Solid Digital PCR to Support Gold-standard Methods for Evaluation of HER2 Amplification Status: Focus on HER2-low Subtype

NCT06813456 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 234

Last updated 2025-02-07

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Sara Coluccelli, PhD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2025-11-01
Completion
2028-12-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06813456 on ClinicalTrials.gov