## Protocol Section
### Identification Module
**NCT ID:** NCT06430359

**Acronym:** VARCUWIC

**Brief Title:** Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients

**Official Title:** Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts

#### Organization Study ID Info
**ID:** 69HCL23_1227
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2025-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations.

Treatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts.

Monitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency.

Nevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine.

There is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine.

According to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon.

The study would aim to find the period of the day best correlated with 24h urinary copper excretion

### Conditions Module

**Conditions:**

- Wilson Disease

**Keywords:**

- Wilson disease

- urinary copper

- chelator

### Design Module

#### Bio Spec

**Description:** 3 urine collections of an 8h period. One blood sample for liver function test and copper assessment

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with D-Pencillamine

**Intervention Names:**

- Diagnostic Test: urine and blood test

**Label:** Group 1 - DP

#### Arm Group 2

**Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Trientine

**Intervention Names:**

- Diagnostic Test: urine and blood test

**Label:** Group 2 - Trientine

#### Arm Group 3

**Description:** Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Zinc.

**Intervention Names:**

- Diagnostic Test: urine and blood test

**Label:** Group 3 - ZINC

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1 - DP

- Group 2 - Trientine

- Group 3 - ZINC

**Description:** 3 urine collections of an 8h period. One blood sample for liver function test and copper assessment

**Name:** urine and blood test

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).

**Measure:** Correlation factor

**Time Frame:** Two 24-hour urine recollection

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
* Age ≥ 6 years and ≤70 years.
* Patient able to perform 24h urine.
* Current treatment with D-Pencillamine, Trientine or Zinc.
* Non-opposition of patient and/or legal representatives for minor patients.

Exclusion Criteria:

* Patients who had a change in treatment within the last 6 months before the inclusion
* Patients who have undergone liver transplantation
* Patients with known chronic renal failure (GFR \< 30 ml/min)
* Patients on long-term diuretic or corticosteroid therapy
* Persons deprived of liberty by a judicial or administrative decision
* Patient under judicial protection, unable to express consent

**Maximum Age:** 70 Years

**Minimum Age:** 6 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** - Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eduardo.couchonnal-bedoya@chu-lyon.fr

**Name:** Eduardo COUCHONNAL, Dr

**Phone:** 04 27 35 70 50

**Phone Ext:** +33

**Role:** CONTACT

**Contact 2:**

**Email:** abdelouahed.belmalih@chu-lyon.fr

**Name:** Abdelouahed BELMALIH, PhD

**Phone:** 04 27 85 62 67

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bron

**Contacts:**

***Contact 1:***

- **Email:** eduardo.couchonnal-bedoya@chu-lyon.fr

- **Name:** Eduardo Couchonnal, Dr

- **Phone:** 04 27 35 70 50

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Email:** abdelouahed.belmalih@chu-lyon.fr

- **Name:** Abdelouahed BELMALIH, PhD

- **Phone:** 04 27 85 62 67

- **Phone Ext:** +33

- **Role:** CONTACT

**Country:** France

**Facility:** Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant

**State:** Rhone

**Zip:** 69500

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020739

- Term: Brain Diseases, Metabolic, Inborn

- ID: D000001928

- Term: Brain Diseases, Metabolic

- ID: D000009069

- Term: Movement Disorders

- ID: D000020271

- Term: Heredodegenerative Disorders, Nervous System

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000008661

- Term: Metabolism, Inborn Errors

- ID: D000008664

- Term: Metal Metabolism, Inborn Errors

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9612

- Name: Hepatolenticular Degeneration

- Relevance: HIGH

- As Found: Wilson Disease

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5205

- Name: Brain Diseases, Metabolic

- Relevance: LOW

- As Found: Unknown

- ID: M22498

- Name: Brain Diseases, Metabolic, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22092

- Name: Heredodegenerative Disorders, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M11641

- Name: Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M11644

- Name: Metal Metabolism, Inborn Errors

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5933

- Name: Wilson Disease

- Relevance: HIGH

- As Found: Wilson Disease

### Condition Browse Module - Meshes

- ID: D000006527

- Term: Hepatolenticular Degeneration

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Mi

- Name: Mineral

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M5860

- Name: Chelating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17768

- Name: Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M6523

- Name: Copper

- Relevance: LOW

- As Found: Unknown

- ID: M17018

- Name: Trientine

- Relevance: LOW

- As Found: Unknown

- ID: T338

- Name: Copper Supplement

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
