NCT00857922

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2009Aug 2030

Study Start

First participant enrolled

March 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

21 years

First QC Date

March 6, 2009

Last Update Submit

August 5, 2025

Conditions

Keywords

NeurologicalNeurosurgical

Outcome Measures

Primary Outcomes (1)

  • Discharge status

    Standardized functional outcome score

    hospital discharge

Study Arms (2)

Neurosurgical patient

Neurosurgical patient of the Mischer Neuroscience Institute, 18 years and over

Other: tissue and data repository

Family members

Family members of specific vascular, trauma, brain tumor and functional disorder cohorts

Other: tissue and data repository

Interventions

Tissue and data will be maintained in a repository for study from consenting subjects.

Family membersNeurosurgical patient

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Neurosurgical patient (primary or consulting); patients\<18 includes residual tissue only, no blood samples.
  • Family members of specific vascular, trauma, brain tumor and functional disorder cohorts (will be identified in future addendums to this repository)

You may not qualify if:

  • \. Inability to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Neurologic Manifestations

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Georgene W Hergenroeder, PhD

    McGovern Medical School at UTHealth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director, PI, Associate Professor

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

March 1, 2009

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

August 7, 2025

Record last verified: 2025-08

Locations