| NCT ID | NCT00857922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Neurological Conditions |
| Study Type | OBSERVATIONAL |
| Enrollment | 15,000 participants |
| Start Date | 2009-03 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15,000 participants in total. It began in 2009-03 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
G Hergenroeder
✉ Georgene.W.Hergenroeder@uth.tmc.eduGeorgene W Hergenroeder, PhD
PRINCIPAL INVESTIGATOR
McGovern Medical School at UTHealth
Frequently Asked Questions
Who can join the NCT00857922 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, studying Neurological Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00857922 currently recruiting?
Yes, NCT00857922 is actively recruiting participants. Contact the research team at Georgene.W.Hergenroeder@uth.tmc.edu for enrollment information.
Where is the NCT00857922 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT00857922 clinical trial?
NCT00857922 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Georgene W Hergenroeder, PhD at McGovern Medical School at UTHealth. The trial plans to enroll 15,000 participants.