Neuroimmunology Branch Repository
|First Received Date ICMJE||April 19, 2012|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||July 14, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Data samples will be analyzed as approved under original protocol and as amended with IRB approval. Data and samples that were obtained with consent for this study or with approval for future use may be analyzed on site or sent to a repository.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01581567 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Neuroimmunology Branch Repository|
|Official Title ICMJE||NIB Repository Protocol|
- Information and samples collected from participants in medical research studies can be useful even after the original study is complete. Researchers can use the information and samples to learn more about multiple sclerosis or other immune system disorders. They can also be used for research into other disorders. Researchers would like to get permission to use samples collected from older studies to launch new lines of research.
- To look at information and samples from earlier National Institutes of Health Neuroimmunology Branch studies.
- People who provided samples and medical information for earlier studies.
The purpose of this protocol is to enable prospective IRB review of research using human samples and data collected under other Neuroimmunology Branch (NIB) protocols and to enable retrospective review of samples and data from the branch s protocols that have been terminated prior to full data analysis and publication.
Subjects who previously participated in NIH protocols for whom we have samples or data whose wishes regarding use of their samples/data for research other than that specified in the initial protocol is not known, or where we would like to use their samples or data for purposes other than those they have consented for may be enrolled in this protocol if they are able to be contacted and consent to additional use of their samples or data.
Data and Sample Ascension
Data and samples may include but are not limited to demographic and personal health information, psychological or psychiatric testing, blood, urine, cerebrospinal fluid (CSF) or other body fluids or tissues, results of medical and/or physiological evaluation, and medical imaging.
Data and samples will enter this protocol from the following terminated IRB-approved protocols under which all human subject enrollment and participation is complete including:
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01581567|
|Other Study ID Numbers ICMJE||110210, 11-N-0210|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Neurological Disorders and Stroke (NINDS)|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 10, 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP