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

Launched by INSTITUTE OF ONCOLOGY LJUBLJANA · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on studying trace elements in the blood of patients with biliary tract cancers, which are cancers affecting the bile ducts and gallbladder. The researchers want to measure the levels of copper, zinc, and iron in the blood, as well as how these trace elements are processed in the body. By comparing samples from healthy volunteers and cancer patients, the study aims to find out if these measurements can help in diagnosing and treating cancer.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with biliary tract cancer confirmed by medical tests. They should not have received any previous treatments like chemotherapy or radiation for their cancer. Participants will undergo blood tests and imaging scans to monitor their condition. It's important to note that those with certain other health issues or prior cancers may not qualify. This study is currently looking for participants, and everyone involved will need to consent to take part in the research.

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Eligibility criteria

• 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.