Clinical trial · Observational
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
A Clinical Performance Study to Validate the Use of Novel Molecular Diagnostic Assays for the Detection of Cancer Biomarkers in Peripheral Blood and Primary Tumor Tissue Samples of Patients With Metastatic ER+/HER2- Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment. Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIK3CA kit | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Metastatic Breast Cancer
- description
- The study population are subjects with a confirmed diagnosis of ER+/HER2 metastatic Breast Cancer patient before the treatment initiation. The selected inclusion/exclusion criteria have been set to include in the performance study appropriate population of interest, as broad as possible, but to exclude these subjects that have another current malignancy or any history of recent malignancy within 3 years.
- interventionNames
- Diagnostic Test: PIK3CA kit
- label
- Healthy volunteers
- description
- In case of healthy volunteers only peripheral blood samples will be collected.
- interventionNames
- Diagnostic Test: PIK3CA kit
Primary outcomes (1)
- measure
- Clinical performance of PIK3CA kit in CTCs, plasma and tumor tissue samples of metastatic breast cancer patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female aged ≥ 18 years of age. 2. Histological confirmed ER+/HER2- metastatic Breast Cancer prior to beginning a treatment 3. Life expectancy permits participation to the study. 4. Available tumor tissue sample for molecular analysis. 5. Signed informed consent form. Exclusion Criteria: 1. Female younger than 18 years old. 2. History of another malignancy within 3 years or current 2nd primary malignancy. 3. Patients that have not signed the informed consent.
References
Publications (0)
Data not yet available