Metastatic Breast Cancer
Conditions
Brief summary
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.
Detailed description
The value of this study is based on the fact that DN-MBC is rare, seems to be different from early and relapsed breast cancer and has not been studied as distinct disease. To achieve the objective of this study blood and tissue sample from patients diagnosed with DN-MBC will be further analyzed using next generation sequencing (NGS), in order to map the molecular/genetic characteristics of DN-MBC and to detect germline and somatic pathogenic variants. All the results will be associated with the clinicopathological characteristics of the patients.
Interventions
DIAGNOSTIC_TESTNGS in blood and Formalin-Fixed Paraffin-Embedded (FFPE) tissue
In patients with denovo metastatic breast cancer blood and tissue sample will be collected and then further analysed using NGS in order to detect somatic and germline pathogenic variants
Sponsors
Hellenic Society of Medical Oncology
Hellenic Cooperative Oncology Group
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with somatic pathogenic variants in denovo metastatic breast cancer | up to 12 months |
| Number of participants with germline pathogenic variants in denovo metastatic breast cancer | up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Definition of the somatic pathogenic variants measured with Next Generation Sequencing | up to 12 months |
| Collection of clinicopathological characteristics of the included patients from patient's medical file | up to 12 months |
| Definition of the germline pathogenic variants measured with Next Generation Sequencing | up to 12 months |
Countries
Greece
Outcome results
None listed