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

NCT06060990 | Recruiting

• 1 other identifier: KME 0120-472/2022/3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Trace Element Deficiency

Keywords

metastatic biliary tract cancer, biomarkers, trace elements

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (1)

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

Other: trace elements

Interventions

trace elements OTHER

trace elements as biomarkers for response to systemic therapy in metastatic BTCs

Open-label single arm of patients with metastatic BTCs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Trace Elements

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Martina Reberšek, MD, PhD

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Reberšek, MD,PhD

CONTACT

00386 15879975; mrebersek@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)