The aim of the study is to determine the total concentration of selected trace elements (Cu, Zn, Fe), the proportion of free Cu and Cu bound to ceruloplasmin and the isotopic ratio of Cu65/Cu63 in blood serum samples from healthy volunteers and cancer patients using inductively coupled plasma mass spectrometry-based methods. The results will be statistically evaluated and the potential applications of the analytical methods used in cancer diagnosis and therapy will be assessed.
aged ≥18 years
cytologically or histologically verified biliary tract cancer
no prior systemic therapy and no radiation therapy for advanced, inoperable or metastatic disease
WHO performance status 0 - 2 (ECOG criteria)
prior systemic treatment and radiation therapy for inoperable, metastatic disease
WHO performance status > 2 (ECOG criteria)
contraindications to immunotherapy (known immunodeficiency or active immunosuppressive therapy or active autoimmune disease requiring treatment)
other malignancies, except cured basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or other cured solid tumours without recurrence ≥ 3 years after treatment.
Single group
trace elements
Other interventiontrace elements as biomarkers for response to systemic therapy in metastatic BTCs
Serum copper (Cu) as a predictive biomarker of the response to systemic treatment of biliary tract cancer patients
The concentration of copper (Cu) in blood serum samples from healthy volunteers and biliary cancer patients will be measured to identify the differences in levels and the ratio between both groups, and to identify the serum Cu levels as a predictive biomarker of response to systemic therapy biliary tract cancer patients in the correlation with radiological CT evaluation.
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