Clinical trial NCT00857922: Neurosciences Research Repository
Official title: Neurosciences Research Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurological Conditions
Keywords: Neurological
Neurosurgical
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-03-09
Enrollment: 15000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: Inclusion Criteria:

1. Neurosurgical patient (primary or consulting); patients\<18 includes residual tissue only, no blood samples.
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

Primary outcomes:
measure: Discharge status
timeFrame: hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: McGovern Medical School at UTHealth
name: Georgene W Hergenroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References: