Evaluation and Treatment of Neurosurgical Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- standard clinical evaluation and treatment
研究概览
简要总结
Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment. The clinical data and samples generated during standard of care treatment will be collected as part of this study.
Study Population: Participants 4 years of age and older with neurosurgical-related conditions, who are seeking care from or referred to the Surgical Neurology Branch for evaluation, are eligible for this protocol.
Study Design: This is an observational study. Participants will receive standard-of-clinical-care evaluation and treatment for their neurosurgical condition. Clinical evaluation may include laboratory and radiological studies designed to aid in diagnosis or differential diagnosis of the participant s condition or to facilitate treatment. The evaluations may take place in the outpatient clinic areas or in the inpatient units. Some participants will receive standard-of-care medical or surgical treatment for their disorder. Clinical data, tissue samples or body fluids obtained during standard of care treatment, may be used for research. Additional genetic testing may be performed on subjects and their blood relatives if a genetic mechanism underlying the neurological disorder is suspected. Patients in this study may choose to consent to skin biopsies for research purposes, in which case they will sign an additional consent document for this research procedure.
Outcome Measures: No additional research outcome measures will be tracked in this study, as this study is collecting data for potential future use. All outcomes will be those of standard clinical evaluation and treatment. A clinical and research database will be kept of patient s diagnosis, progression, and treatment. Clinical database information may be reported or be used in other studies.
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详细描述
Objective
This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment. The clinical data and samples generated during standard of care treatment will be collected as part of this study.
Study Population: Participants 4 years of age and older with neurosurgical-related conditions, who are seeking care from or referred to the Surgical Neurology Branch for evaluation, are eligible for this protocol.
Study Design: This is an observational study. Participants will receive standard-of-clinical-care evaluation and treatment for their neurosurgical condition. Clinical evaluation may include laboratory and radiological studies designed to aid in diagnosis or differential diagnosis of the participant s condition or to facilitate treatment. The evaluations may take place in the outpatient clinic areas or in the inpatient units. Some participants will receive standard-of-care medical or surgical treatment for their disorder. Clinical data, tissue samples or body fluids obtained during standard of care treatment, may be used for research. Additional genetic testing may be performed on subjects and their blood relatives if a genetic mechanism underlying the neurological disorder is suspected. Patients in this study may choose to consent to skin biopsies for research purposes, in which case they will sign an additional consent document for this research procedure.
Outcome Measures: No additional research outcome measures will be tracked in this study, as this study is collecting data for potential future use. All outcomes will be those of standard clinical evaluation and treatment. A clinical and research database will be kept of patient s diagnosis, progression, and treatment. Clinical database information may be reported or be used in other studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Participants must be age 4 and older.
- •Participants must seek care from, or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)
- •For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated
- •For minors: a parent or legal guardian who is able to provide consent.
- •For immediate blood relatives of subjects having genetic testing only:
- •Blood relative of a subject who is suspected to have a genetic mechanism underlying their neurological disorder (for genetic testing only).
排除标准
- •1. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder
- •3.c. Participant Inclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)
- •Participants must be age 4 and older.
- •Participants must seek care from or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)
- •For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated
- •For minors: a parent or legal guardian who is able to provide consent.
- •Be willing to consent for collection of clinical data or biological samples or their cryopreservation
- •3.D. Participant Exclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)
- •Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder
- •At the time of enrollment, subjects without an established diagnosis of a wellcharacterized disease entity with validated treatment algorithms. In such cases, proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge
研究组 & 干预措施
Patients
Patients age 4 or older who are seeking care from or being referred to the Surgical Neurology Branch for evaluation, and management of neurosurgical conditions
干预措施: Laboratory tests (Procedure)
Patients
Patients age 4 or older who are seeking care from or being referred to the Surgical Neurology Branch for evaluation, and management of neurosurgical conditions
干预措施: Radiological exams (Procedure)
结局指标
主要结局
standard clinical evaluation and treatment
时间窗: ongoing
standard clinical evaluation and treatment
次要结局
未报告次要终点