## Protocol Section
### Identification Module
**NCT ID:** NCT02222779

**Brief Title:** Quantification of Transition Metals

**Official Title:** Quantification of Transition Metals in Patients at the Cologne University Hospital

#### Organization Study ID Info
**ID:** KPUK-14-Metal
#### Organization
**Class:** OTHER
**Full Name:** University of Cologne
### Status Module
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2014-08-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-08-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-09

**Status Verified Date:** 2014-08

#### Study First Post Date
**Date:** 2014-08-21
**Type:** ESTIMATED
**Study First Submit Date:** 2014-08-20
**Study First Submit QC Date:** 2014-08-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Cologne

#### Responsible Party

**Investigator Affiliation:** University of Cologne

**Investigator Full Name:** Ali Mohammad Nejad Sigaroudi

**Investigator Title:** Quantification of Transition Metals in Patients at the Cologne University Hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** In this trial, concentrations of transition metals of interest are quantified in surplus cerebrospinal fluid (CSF) and blood serum samples. Quantification of the transition metals will be performed by inductively coupled plasma mass spectrometry (ICP-MS). The treating physicians as well as the patients will not be informed about the results of drug concentrations.

**Detailed Description:** Samples used include:

Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and blood serum samples). No lumbar puncture will be done specifically for this protocol.

The objective of this study is to gain an overview about transition metals concentrations in blood serum and CSF in order to provide preliminary data on patients. The effect of neurodegenerative diseases on metals or the other way round will be assessed if possible.

### Conditions Module

**Conditions:**

- Neurodegenerative Diseases

- Infections

### Design Module

#### Bio Spec

**Description:** Remaining portions of samples collected for diagnostic or therapeutic reasons (paired CSF and blood serum samples). No lumbar puncture will be done specifically for this protocol.

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** ECOLOGIC_OR_COMMUNITY

#### Enrollment Info

**Count:** 3000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** Patients with Parkinson´s Disease

#### Arm Group 2

**Label:** Patient´s with Alzheimer´s Disease

#### Arm Group 3

**Label:** Patients with Multiple Sclerosis

#### Arm Group 4

**Label:** Patients with any other neurodegenerative diseases

### Outcomes Module

#### Primary Outcomes

**Measure:** Transition metal concentration

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria: •

* The trial will include any patient (with various diseases, especially neurodegenerative diseases) who received a lumbar puncture.

Exclusion Criteria:

* • The lower age limit is 18 years. In concordance with the objective of the project there is no specific exclusion criteria.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** neurodegenerative diseases infections

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** uwe.fuhr@uk-koeln.de

**Name:** Uwe Fuhr, Professor

**Phone:** 0049221478

**Phone Ext:** 5230

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cologne

**Contacts:**

***Contact 1:***

- **Email:** uwe.fuhr@uk-koeln.de

- **Name:** Uwe Fuhr, Professor

- **Phone:** 0049221478

- **Phone Ext:** 5230

- **Role:** CONTACT

**Country:** Germany

**Facility:** Department of Pharmacology

**State:** Northrhine Westphalia

**Zip:** 50829

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: HIGH

- As Found: Neurodegenerative Diseases

### Condition Browse Module - Meshes

- ID: D000019636

- Term: Neurodegenerative Diseases

### Misc Info Module

- Version Holder: 2024-05-24
