Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers

Summary

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.

Eligibility

Inclusion Criteria:

* 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)
* imaging diagnosis (CT of thoracic and abdominal organs) performed within 4 weeks prior to the first administration of systemic therapy
* disease measurable by RECIST or ECOG criteria
* signed Consent to Participate in Clinical Research form

Exclusion 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.

Conditions2

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