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Cerebrospinal Fluid Collection and Repository Storage

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ClinicalTrials.gov Identifier: NCT01862107
Recruitment Status : Recruiting
First Posted : May 24, 2013
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Description
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Brief Summary:

Background:

- Cerebrospinal fluid (CSF) is the liquid around the brain and spinal cord. Many diseases can only be diagnosed by examining the CSF. A lumbar puncture is used to collect and test CSF. Once someone is already having a lumbar puncture, a small extra amount of CSF can be collected at the same time. This fluid can be used to study brain, nerve, and related health issues. Researchers want to collect CSF and blood samples from people who are scheduled to have a lumbar puncture.

Objectives:

- To collect cerebrospinal fluid and blood samples from individuals who are having a lumbar puncture.

Eligibility:

- Individuals between 2 and 100 years of age who are scheduled to have a lumbar puncture for clinical or research purposes.

Design:

  • Participants will have a lumbar puncture for clinical or research purposes.
  • During the procedure, an additional sample of CSF will be collected. They will also provide a blood sample, if one is not taken at the time of the procedure.
  • Treatment will not be provided as part of this study.

Condition or disease
Nervous System Diseases

Detailed Description:
In this study we are planning to establish a repository of cerebrospinal fluid (CSF), serum, and plasma. We are planning to collect a small amount of additional CSF and blood on subjects who are already going to have a lumbar puncture as part of their research or clinical care at the National Institutes of Health (NIH). This will allow us to study whether there is an association between neurological diseases and biomarkers, help identify novel pathogens infecting the central nervous system, and better enable us to understand the immune response to infections under future protocols. CSF and blood as well as clinical data associated with the samples will be stored securely.
Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Other
Official Title: Cerebrospinal Fluid Collection and Repository Storage
Actual Study Start Date : July 29, 2013
Estimated Primary Completion Date : May 9, 2029
Estimated Study Completion Date : April 30, 2063

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Healthy Volunteer
Any healthy volunteer getting a lumbar puncture done for either clinical care or research purposes.
Patient
Any patient getting a lumbar puncture done for either clinical care or research purposes.


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this study is to create a repository of CSF and matched serum and plasma samples. [ Time Frame: ongoing ]
    Repository of CSF and matched blood.


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study is a collection of CSF from any patient getting a lumbar puncture done at the Clinical Center for clinical care.
Criteria
  • SUBJECT INCLUSION CRITERIA:
  • Subjects (patients and healthy volunteers) 2 years of age and older identified to undergo LP for research or for clinical care purposes at the NIH Clinical Center.

SUBJECT EXCLUSION CRITERIA:

-Subjects (patients and healthy volunteers) with the inability to provide informed consent either directly or via a legally authorized representative.

Inclusion of Vulnerable Subjects - Research Involving Adults Who Are Or May Be Unable To Consent:

-The risks to all subjects involved in this research project are no more than minimal risk as we are only collecting additional CSF and plasma during a LP procedure that is already being performed under a separate research protocol or as a clinically indicated procedure. At the time of the LP it will already be determined if the subject is able to give informed consent and if not a legally authorized representative will have been appointed who will decide if the additional CSF and plasma can be obtained from the individual.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862107


Contacts
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Contact: Amanda M Wiebold (301) 594-5194 amanda.wiebold@nih.gov
Contact: Avindra Nath, M.D. (301) 496-1561 natha@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Avindra Nath, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
More Information
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Additional Information:

Publications:

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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT01862107    
Other Study ID Numbers: 130140
13-N-0140
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Biomarkers
Immune Responses
Lumbar Puncture
Neurological Diseases
Novel Pathogens
Additional relevant MeSH terms:
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Nervous System Diseases