Predictive Role of New Biomarkers for Hypersensitive Patients to Radiation in Breast Cancer (BIORISE)

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sample: Pre-treatment blood samples will be collected for downstream analyses: * Three 6 ml EDTA samples for proteomic and genomic work package * One 6 ml dry sample for auto-antibodies analysis in the immunology work package * Two 4 ml EDTA samples for DNA extraction in the immunology work package * Two 2.5 ml PAX Gene sample for RNA extraction in the immunology work package and the non-irradiated control in the genomic work package

Study summary

To confirm the protein expression level in radiation-induced late effects patients and to determine the performance value, in particular the positive predictive value, of a blood test based on the dosage of a panel of five proteins, it is necessary to validate these preliminary results by a prospective study on a large cohort of patients.

Eligibility

Primary outcome measure(s)

• blood sample to assess dosage of 5 proteins — through study completion, an average of 5 years
  Confirm the predictive value, of a blood test based on the dosage of a panel of five (5) proteins: AK2 - IDH2 - ANX1- APEX1 - HSC70 in radiation-induced late side effects after breast-conserving surgery and curative intent adjuvant radiotherapy.

Trial sites (1)

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