Trace Element DeficiencyNCT06060990
Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers
A study testing trace elements in people with Trace Element Deficiency, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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 blood serum samples from healthy volunteers and cancer patients using inductively coupled plasma mass spectrometry-based… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Trace Element Deficiency
- What is being tested?
- trace elements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana
Martina Reberšek, MD, PhD, 00386 15879975, mrebersek@onko-i.si
About this study
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.
Read the 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 enzymes, regulate important biological processes by binding to specific receptors and transcription factors. Their concentration in the organism is influenced by many factors such as gender, age, food, environmental pollution, etc. Deregulation of trace metal homeostasis, both at the cellular and tissue level, is part of the pathology of many cancers. It accelerates the transformation of normal cells into cancerous ones, and alters the inflammatory and anti-tumour response of immune cells such as macrophages). Knowledge of the role of essential trace metals in cancer is important for the development of modern pharmaceutical and nutritional approaches aimed at restoring the balance of trace elements in the body and enhancing the beneficial effects of systemic oncological therapy. At the same time, the results of modern research on the imbalance of essential trace metals point to their usefulness in cancer diagnosis and therapy. Biliary tract cancers (BTCs) are a heterogeneous group of uncommon and rare epithelial tumours. Surgery is the only potential curative treatment for BTCs, but approximately 70% of patients are diagnosed at advanced stages due to absence of specific symptoms in early stage. Tumour markers can be diagnostic, for tumour screening and early detection, prognostic or predictive for response to systemic oncological therapy. However, widely accepted biomarkers for diagnosing and dynamically monitoring the BTCs are still lacking. Currently applied tumour markers CA 19-9 and CEA, have limited diagnostic value for BTCs because they don't have high sensitivity and specificity for BTCs. Trace elements as biomarkers in oncology are new research field for detecting, diagnosing and prediction of response to treatment.
- Conditions
- Trace Element Deficiency
- Being tested
- trace elements
- Keywords
- metastatic biliary tract cancer, biomarkers, trace elements
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trace elementsOther
trace elements as biomarkers for response to systemic therapy in metastatic BTCs
| Study group | Role | What they receive |
|---|---|---|
| Open-label single arm of patients with metastatic BTCs | Other | Systemic therapy:
Identification of trace elements as novel predictive and prognostic biomarkers for response to systemic therapy in metastatic BTCs Receives: Other: trace elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum copper (Cu) as a predictive biomarker of the response to systemic treatment of biliary tract cancer patients
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trace Element DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martina Reberšek, MD, PhD, Principal investigator, Institute of Oncology Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060990
- Sponsor's protocol ID
- KME 0120-472/2022/3
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers
- ClinicalTrials.gov ID
- NCT06060990
- Acronym / sponsor ID
- KME 0120-472/2022/3
- Conditions
- Trace Element Deficiency
- Keywords
- metastatic biliary tract cancer, biomarkers, trace elements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 enzymes, regulate important biological processes by binding to specific receptors and transcription factors. Their concentration in the organism is influenced by many factors such as gender, age, food, environmental pollution, etc. Deregulation of trace metal homeostasis, both at the cellular and tissue level, is part of the pathology of many cancers. It accelerates the transformation of normal cells into cancerous ones, and alters the inflammatory and anti-tumour response of immune cells such as macrophages). Knowledge of the role of essential trace metals in cancer is important for the development of modern pharmaceutical and nutritional approaches aimed at restoring the balance of trace elements in the body and enhancing the beneficial effects of systemic oncological therapy. At the same time, the results of modern research on the imbalance of essential trace metals point to their usefulness in cancer diagnosis and therapy. Biliary tract cancers (BTCs) are a heterogeneous group of uncommon and rare epithelial tumours. Surgery is the only potential curative treatment for BTCs, but approximately 70% of patients are diagnosed at advanced stages due to absence of specific symptoms in early stage. Tumour markers can be diagnostic, for tumour screening and early detection, prognostic or predictive for response to systemic oncological therapy. However, widely accepted biomarkers for diagnosing and dynamically monitoring the BTCs are still lacking. Currently applied tumour markers CA 19-9 and CEA, have limited diagnostic value for BTCs because they don't have high sensitivity and specificity for BTCs. Trace elements as biomarkers in oncology are new research field for detecting, diagnosing and prediction of response to treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Open-label single arm of patients with metastatic BTCs | Other | Other: trace elementsSystemic therapy: Identification of trace elements as novel predictive and prognostic biomarkers for response to systemic therapy in metastatic BTCs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trace elementstrace elements as biomarkers for response to systemic therapy in metastatic BTCs | Other | Open-label single arm of patients with metastatic BTCs |
Primary outcome
Serum copper (Cu) as a predictive biomarker of the response to systemic treatment of biliary tract cancer patients
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martina Reberšek, MD, PhD principal investigator
Institute of Oncology Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trace elements in people with Trace Element Deficiency, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Reberšek, MD,PhD (00386 15879975, mrebersek@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum copper (Cu) as a predictive biomarker of the response to systemic treatment of biliary tract cancer patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.