Clinical trial · Observational
Detection of Germline and Somatic Pathogenic Variants in Patients With de Novo Metastatic Breast Cancer
NCT05758948CI-TRIAL-00065441unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
To determine somatic and germline pathogenic variants in patients with denovo metastatic breast cancer in order to map the molecular/genetic characteristics of DN- MBC aiming in comprehending the biology and highlighting potential novel treatment options for the disease.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NGS in blood and Formalin-Fixed Paraffin-Embedded (FFPE) tissue | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with de novo metastatic breast cancer
- description
- Blood and tissue sample from patients diagnosed with DN-MBC will be analyzed using next generation sequencing (NGS)
- interventionNames
- Diagnostic Test: NGS in blood and Formalin-Fixed Paraffin-Embedded (FFPE) tissue
Primary outcomes (2)
- measure
- Number of participants with somatic pathogenic variants in denovo metastatic breast cancer
- timeFrame
- up to 12 months
- measure
- Number of participants with germline pathogenic variants in denovo metastatic breast cancer
- timeFrame
- up to 12 months
Secondary outcomes (3)
- measure
- Definition of the somatic pathogenic variants measured with Next Generation Sequencing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent for the provision of the biological material for research purposes 2. Diagnosis of de novo MBC (histologically confirmed) 3. Age \>18 years 4. Blood samples 5. Tumor tissue block from at least on disease site, primary (preferably) or metastatic Exclusion Criteria: Inadequate MBC tissue
References
Publications (0)
Data not yet available
No reference posted for this study.