Hereditary Breast Cancer Clinical Trial
Official title:
Comparative, Multicenter Study Estimating Association Between Germline DNA-repair Genes Mutations and PD-L1 Expression Level in Breast Cancer
This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the association between the presence of germline DNA-repair genes mutations and PD-L1 expression level in tumour and immune cells in breast cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients.
Status | Recruiting |
Enrollment | 390 |
Est. completion date | July 1, 2019 |
Est. primary completion date | March 17, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 1. The voluntary obtained informed consent signed by both the subject and the investigator. 2. Females 18 years age or more. 3. Histologically confirmed BC with known hormone receptors and HER2neu receptors status, Grade of tumor, diagnosed before enrolment into the study. 4. Availability of FFPE tissue samples received prior to any type of antitumor treatment start. Tumour tissue samples must be satisfied IHC requirements for PD-L1 testing. 5. Ability of blood samples receiving for NGS germline mutations testing. 6. Completed medical records (stage, receptors status, demographic data) Exclusion Criteria: - Any evidence of uncontrolled system pathology, active infections, active bleeding diathesis, renal graft, including virus hepatitis B, C or HIV. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Tatarstan Cancer Cente | Kazan | Tatarstan |
Lead Sponsor | Collaborator |
---|---|
Tatarstan Cancer Center |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic performance of PD-L1 expression in breast cancer | Number of samples of PD-L1 high expression in tumor and immune cells in FFPE breast tumor tissue and number of samples of PD-L1 low expression in tumor and immune cells in FFPE breast tumor tissue . The report will be represented as "PD-L1 high" or "PD-L1 low". |
January 2018-January 2019 | |
Secondary | Diagnostic performance of inherited gene mutations in breast cancer | Mutations will be determined by "pathogenic" and "non pathogenic". Number of samples with "pathogenic" and "non pathogenic" mutations . | January 2018-January 2019 | |
Secondary | Association between germline DNA-repair genes mutations and PD-L1 expression level in in breast cancer | To reveal the differences (percentages) of PD-L1 high tumor rate between patients with hereditary BC ( pathogenic mutations) who have clinically significant germline mutations in DNA-repair genes (HR- deficiency) and patients with sporadic BC without such mutations (non pathogenic mutations). | January 2018-January 2019 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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