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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02222779
Other study ID # KPUK-14-Metal
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 20, 2014
Last updated August 20, 2014
Start date September 2014

Study information

Verified date August 2014
Source University of Cologne
Contact Uwe Fuhr, Professor
Phone 0049221478
Email uwe.fuhr@uk-koeln.de
Is FDA regulated No
Health authority Germany: no higher federal authority needed due to being a non-interventional study
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date
Est. primary completion date August 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Ecologic or Community


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Pharmacology Cologne Northrhine Westphalia

Sponsors (1)

Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transition metal concentration 5 years
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