Clinical trial · Interventional
Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers
NCT06060990CI-TRIAL-00081713recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Trace Element Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trace elements | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Open-label single arm of patients with metastatic BTCs
- description
- Systemic therapy: Identification of trace elements as novel predictive and prognostic biomarkers for response to systemic therapy in metastatic BTCs
- interventionNames
- Other: trace elements
Primary outcomes (1)
- measure
- Serum copper (Cu) as a predictive biomarker of the response to systemic treatment of biliary tract cancer patients
- timeFrame
- 3 years
- description
- The concentration of copper (Cu) in blood serum samples from healthy volunteers and biliary cancer patients will be measured to identify the differences in levels and the ratio between both groups, and to identify the serum Cu levels as a predictive biomarker of response to systemic therapy biliary tract cancer patients in the correlation with radiological CT evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.