Neurosciences Research Repository (NRR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
The Vivian L. Smith Center for Neurologic Research
Information provided by (Responsible Party):
Georgene Hergenroeder, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00857922
First received: March 6, 2009
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

In order to expand neuroscience research and move laboratory advances to patients, there is a need to integrate reliable clinical data with biologic information from patient tissue specimens. The Neuroscience Research Repository (NRR) seeks to meet this need. The NRR is a prospective database and sample bank created to collect information and samples for current and future neuroscience research. The objective of this NRR is to develop a data and sample repository for study of neurological conditions. A repository utilizing standardized electronic health data and samples collected in a uniform manner serves to foster the ability to perform research on current and future projects. Samples and data for clinical, genomic and proteomic analysis will be provided to optimize their value for neuroscience research.

The NRR will enroll patients and collect clinically recorded longitudinal data for as long as they are followed by the Neurosurgery service and up to an additional 5 years after being released from care. Patients will be enrolled on admission to the service and samples will be taken at three time points: Time One, within 24 hours of event (preferably first blood draw); Time Two, within 48 hours of event; and Time Three, time of any residual tissue availability. Family members of select groups of patients will also be approached for enrollment.

Samples and data will be labeled with a study code to maintain confidentiality. Samples and data will be maintained in secure, limited access environments with back-up/redundancy procedures in place. Sample inventory will be maintained with a bar-coding system. A duty to warn clause will be included in the consent as will the determination of willingness to be re-contacted for future research. Time of sample acquisition to time of sample processing will be documented for quality control purposes. Freezers will be monitored for temperature stability. Recipient investigators will be requested to provide feedback on sample quality. Samples will be distributed to neuroscience investigators after approval from the Neurosurgery Scientific Review Committee - Dissemination Review Committee and the Committee for the Protection of Human Subjects (CPHS).


Condition Intervention
Neurological Conditions
Other: tissue and data repository

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neurosciences Research Repository

Further study details as provided by The University of Texas Health Science Center, Houston:

Biospecimen Retention:   Samples With DNA

whole blood, plasma, white cells, saliva, tissue, CSF


Estimated Enrollment: 5000
Study Start Date: March 2009
Estimated Study Completion Date: August 2029
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Neurosurgical patient
Neurosurgical patient of the Mischer Neuroscience Institute, 18 years and over
Other: tissue and data repository
Tissue and data will be maintained in a repository for study from consenting subjects.
Family members
Family members of specific vascular, trauma, brain tumor and functional disorder cohorts
Other: tissue and data repository
Tissue and data will be maintained in a repository for study from consenting subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients admitted to the Neurosurgery service (Mischer Neuroscience Institute/UT Department of Neurosurgery or Neurosurgical Critical Care service) are eligible for this study. Family members of those with select conditions will be approached for enrollment at a future date.

Criteria

Inclusion Criteria:

  1. Neurosurgical patient (primary or consulting)
  2. Family members of specific vascular, trauma, brain tumor and functional disorder cohorts (will be identified in future addendums to this repository)

Exclusion Criteria:

  1. Inability to obtain informed consent
  2. Subjects < 18 years of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857922

Contacts
Contact: Georgene W Hergenroeder, BSN MHA, RN Georgene.W.Hergenroeder@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
The Vivian L. Smith Center for Neurologic Research
Investigators
Principal Investigator: Dong H Kim, MD Mischer Neuroscience Institute/UTHSC-H
Study Director: Georgene W Hergenroeder, BSN MHA, RN UTHSC-H
  More Information

Additional Information:
No publications provided

Responsible Party: Georgene Hergenroeder, Assistant Professor - Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00857922     History of Changes
Other Study ID Numbers: HSC-MS-08-0413
Study First Received: March 6, 2009
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Neurological
Neurosurgical

ClinicalTrials.gov processed this record on October 21, 2014