An observational study in Metastatic Breast Cancer, sponsored by Hellenic Cooperative Oncology Group. Status unknown at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Hellenic Cooperative Oncology Group · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 101 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hellenic Cooperative Oncology Group is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients will be selected from community or academic or private hospitals
Exclusion Criteria:
Inadequate MBC tissue
Blood and tissue sample from patients diagnosed with DN-MBC will be analyzed using next generation sequencing (NGS)
Diagnostic Test: NGS 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
Number of participants with somatic pathogenic variants in denovo metastatic breast cancer
Time frame: up to 12 months
Number of participants with germline pathogenic variants in denovo metastatic breast cancer
Time frame: up to 12 months
Definition of the somatic pathogenic variants measured with Next Generation Sequencing
Time frame: up to 12 months
Collection of clinicopathological characteristics of the included patients from patient's medical file
Time frame: up to 12 months
Definition of the germline pathogenic variants measured with Next Generation Sequencing
Time frame: up to 12 months
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Hellenic Cooperative Oncology Group