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| Name | Class |
|---|---|
| Hellenic Society of Medical Oncology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with de novo metastatic breast cancer | Blood and tissue sample from patients diagnosed with DN-MBC will be analyzed using next generation sequencing (NGS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGS in blood and Formalin-Fixed Paraffin-Embedded (FFPE) tissue | Diagnostic Test | 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 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Inadequate MBC tissue
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patients will be selected from community or academic or private hospitals
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| Name | Affiliation | Role |
|---|---|---|
| EVANGELIA MOIROGIORGOU | YGEIA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelia Moirogiorgou | Athens | Greece |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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blood and Formalin-Fixed Paraffin-Embedded (FFPE) tissue specimens
| Definition of the germline pathogenic variants measured with Next Generation Sequencing | up to 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007159 | Immunologic Tests |
| D007158 | Immunologic Techniques |