Status:
RECRUITING
Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Trace Element Deficiency
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 blo...
Detailed Description
Copper, zinc and iron (Cu, Zn and Fe) are among the trace metals that are essential for the normal functioning of the human body. They are involved in many biochemical reactions, are cofactors of enzy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06060990
Start Date
January 1 2023
End Date
January 1 2026
Last Update
October 17 2024
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia