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

Primary Purpose

Trace Element Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
trace elements
Sponsored by
Institute of Oncology Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Trace Element Deficiency focused on measuring metastatic biliary tract cancer, biomarkers, trace elements

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute of Oncology LjubljanaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-label single arm of patients with metastatic BTCs

Arm Description

Systemic therapy: Identification of trace elements as novel predictive and prognostic biomarkers for response to systemic therapy in metastatic BTCs

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 27, 2023
Sponsor
Institute of Oncology Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT06060990
Brief Title
Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers
Official Title
Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Oncology Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trace Element Deficiency
Keywords
metastatic biliary tract cancer, biomarkers, trace elements

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-label single arm of patients with metastatic BTCs
Arm Type
Other
Arm Description
Systemic therapy: Identification of trace elements as novel predictive and prognostic biomarkers for response to systemic therapy in metastatic BTCs
Intervention Type
Other
Intervention Name(s)
trace elements
Intervention Description
trace elements as biomarkers for response to systemic therapy in metastatic BTCs
Primary Outcome Measure Information:
Title
Serum copper (Cu) as a predictive biomarker of the response to systemic treatment of biliary tract cancer patients
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Reberšek, MD,PhD
Phone
00386 15879975
Email
mrebersek@onko-i.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Reberšek, MD, PhD
Organizational Affiliation
Institute of Oncology Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Reberšek, MD, PhD
Phone
00386 15879975
Email
mrebersek@onko-i.si

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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