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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitute of Oncology Ljubljana

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • trace elements

Treatment groups

20 Participants
are divided into 1 treatment group