CompletedNot Applicable

Exchangeable and Relative Exchangeable Copper as an Alternative to 24-Hour Urinary Copper in Wilson's Disease Monitoring

Turkey (Türkiye)81 participantsStarted 2021-01-31

Plain-language summary

Serum exchangeable copper (EC) and relative exchangeable copper (REC) are blood tests developed to improve the assessment of copper levels in patients with Wilson's disease. EC measures the fraction of copper in the blood that is not bound to ceruloplasmin and reflects copper accumulation in the body. REC represents the proportion of this exchangeable copper relative to total serum copper. Previous studies have shown that EC and REC are more accurate than traditional copper tests for diagnosing Wilson's disease. This study aimed to evaluate the relationship between EC/REC and routine copper measurements in patients with Wilson's disease during follow-up, to assess their potential value in disease monitoring.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Wilson's Disease Group: * Adult patients (≥18 years) diagnosed with Wilson's disease * Followed at gastroenterology and/or neurology clinics * Clinically stable at the time of study inclusion * Provided written informed consent Control Group: * Adult patients (≥18 years) with dyspepsia * No known diagnosis of Wilson's disease or other disorders of copper metabolism * Age- and sex-matched to patients with Wilson's disease * Provided written informed consent Exclusion Criteria: (Applied to both groups unless otherwise specified) * Acute liver-related disease or complications, including: * Acute liver failure * Acute-on-chronic liver failure * Spontaneous bacterial peritonitis * Hepatic encephalopathy * Hepatorenal syndrome * Presence of diseases affecting copper metabolism other than Wilson's disease, including: Menkes disease, Malnutrition, Malabsorption syndromes * Inability or unwillingness to provide informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation Between Serum Exchangeable Copper and 24-hour Urinary Copper Excretion in Wilson's Disease

Timeframe: Day 1

Correlation Between Serum Exchangeable Copper and Total Serum Copper in Wilson's Disease and Controls

Timeframe: Day 1

Assessment of Correlation Between Relative Exchangeable Copper and Urinary Copper Excretion in Wilson's Disease

Timeframe: Day 1

Trial details

NCT IDNCT07462026

SponsorHacettepe University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-09-05

View on ClinicalTrials.gov More Wilson's Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Correlation Between Serum Exchangeable Copper and 24-hour Urinary Copper Excretion in Wilson's Disease

Timeframe: Day 1

Correlation Between Serum Exchangeable Copper and Total Serum Copper in Wilson's Disease and Controls

Timeframe: Day 1

Assessment of Correlation Between Relative Exchangeable Copper and Urinary Copper Excretion in Wilson's Disease

Timeframe: Day 1