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Trial Title:
Detection of Germline and Somatic Pathogenic Variants in Patients With de Novo Metastatic Breast Cancer
NCT ID:
NCT05758948
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Formaldehyde
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
NGS in blood and Formalin-Fixed Paraffin-Embedded (FFPE) tissue
Description:
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
Arm group label:
Patients diagnosed with de novo metastatic breast cancer
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.
Criteria for eligibility:
Study pop:
patients will be selected from community or academic or private hospitals
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Evangelia Moirogiorgou
Address:
City:
Athens
Country:
Greece
Start date:
July 5, 1998
Completion date:
June 2023
Lead sponsor:
Agency:
Hellenic Cooperative Oncology Group
Agency class:
Other
Collaborator:
Agency:
Hellenic Society of Medical Oncology
Agency class:
Other
Source:
Hellenic Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05758948
