Measuring trace elements in blood from patients with biliary tract cancers
Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers
NA · Institute of Oncology Ljubljana · NCT06060990
This study is testing the levels of trace elements like copper and zinc in the blood of patients with biliary tract cancers to see if they can help with cancer diagnosis and treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana (other) |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06060990 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the concentrations of trace elements such as copper, zinc, and iron in serum samples from patients diagnosed with biliary tract cancers. Using advanced inductively coupled plasma mass spectrometry, the study will evaluate the total levels of these elements, their binding forms, and isotopic ratios. The findings will be statistically assessed to explore their potential applications in cancer diagnosis and therapy, particularly in understanding the role of trace metals in cancer pathology and treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with cytologically or histologically verified biliary tract cancer who have not received prior systemic or radiation therapy.
Not a fit: Patients with a WHO performance status greater than 2 or those who have received prior systemic treatment for metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cancer diagnosis and therapy by identifying trace element imbalances that may influence treatment outcomes.
How similar studies have performed: While the role of trace elements in cancer is being explored, this specific approach using mass spectrometry for biliary tract cancers is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (RECRUITING)
Study contacts
- Principal investigator: Martina Reberšek, MD, PhD — Institute of Oncology Ljubljana
- Study coordinator: Martina Reberšek, MD,PhD
- Email: mrebersek@onko-i.si
- Phone: 00386 15879975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Trace Element Deficiency, metastatic biliary tract cancer, biomarkers, trace elements