Clinical trial NCT06636201: Large-scale Multi-omics Analysis of Cerebrospinal Fluid
Official title: Deputy Director of Department of Neurosurgery, the Second Affiliated Hospital of Zhejiang University School of Medicine；Professor；
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Keywords: biomarker
aging
neurodegenerative disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for spinal anesthesia surgery due to non-neurological conditions and pediatric patients undergoing surgery for tethered spinal cord syndrome.

Brief summary: The aim of this study is to explore the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases.

Detailed description: This study aims to investigate the role of cerebrospinal fluid (CSF) biomarkers in aging and neurodegenerative diseases, with a focus on the following objectives:

Analysis of Age-Related Changes in CSF Biomarkers: The study will analyze CSF samples from different age groups to identify biomarkers that undergo significant changes during the aging process. This includes the investigation of amyloid-beta (Aβ42), Tau proteins (including the phosphorylated form p-tau181), and other proteins related to neuroinflammation and blood-brain barrier function.

Development of a Predictive Model for Early Diagnosis: By categorizing and quantifying CSF proteins across various age groups, the study aims to establish a predictive model for the early diagnosis of neurodegenerative diseases, such as Alzheimer's disease. The ability to detect these diseases before clinical symptoms emerge could enable early intervention and treatment, offering a crucial window for therapeutic strategies.

Investigation of Dynamic Changes in CSF Biomarkers Across Disease Stages: The study will examine the dynamic changes in CSF biomarkers at different stages of neurodegenerative diseases, including early, middle, and late stages. Understanding the role of these biomarkers in disease progression will provide insights into the pathological processes and potential therapeutic windows.

Creation of a Comprehensive CSF Biomarker Database: A database will be established, encompassing CSF biomarkers from various age groups, disease states, and treatment responses. This resource will be invaluable for future research, facilitating the scientific community's understanding of neurodegenerative diseases and the development of new therapeutic approaches.

Through the achievement of these objectives, this study aims to advance the application of CSF biomarkers in neuroscience research and clinical practice, ultimately improving the diagnosis, management, and treatment of aging-related and neurodegenerative conditions.

Eligibility criteria: 1. Inclusion Criteria:

   * Patients aged 0 to 90 years will be selected for the study.
   * Patients admitted for surgery under spinal anesthesia due to non-neurological conditions, such as lower limb fractures or hemorrhoids.
   * Pediatric patients undergoing surgical treatment for tethered spinal cord syndrome.
2. Exclusion Criteria:

   * Patients with neurological conditions, including encephalitis, Parkinson's disease, Alzheimer's disease, hydrocephalus, brain tumors, and psychiatric disorders.

Primary outcomes:
measure: Cerebrospinal fluid (CSF) biomarkers
timeFrame: December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: