Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
Study NCT ID:
NCT06890702
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of New Biomarkers for Ischemic Cerebrovascular Disease
Sponsor:
Tongji Hospital
Organization:
Study Overview
Official Title:
A Prospective Observational Cohort Study of Predictive Biomarkers Related With Ischemic Cerebrovascular Disease
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this single-center prospective observational study is to identify and evaluate new biomarkers for ischemic cerebrovascular disease (ICVD) to aid in early diagnosis, individualized treatment planning, and prognosis prediction in affected patients. The main questions it aims to answer are:
Can specific biomarkers help in identifying high-risk individuals before disease onset? Can these biomarkers predict disease progression and treatment response? Researchers will compare patients diagnosed with ICVD and healthy controls from a medical check-up center to assess differences in biomarker expression and their clinical significance.
Participants will:
Provide blood, cerebrospinal fluid, urine, and stool samples for biomarker analysis.
Undergo clinical imaging (CT, MRI, PET-CT) and functional assessments. Be followed up at 3, 6, 12, 24, 36, and 48 months for clinical outcomes and biomarker changes.
This study aims to develop a comprehensive biomarker-based prediction model to enhance the diagnosis and management of ischemic cerebrovascular disease.
Can specific biomarkers help in identifying high-risk individuals before disease onset? Can these biomarkers predict disease progression and treatment response? Researchers will compare patients diagnosed with ICVD and healthy controls from a medical check-up center to assess differences in biomarker expression and their clinical significance.
Participants will:
Provide blood, cerebrospinal fluid, urine, and stool samples for biomarker analysis.
Undergo clinical imaging (CT, MRI, PET-CT) and functional assessments. Be followed up at 3, 6, 12, 24, 36, and 48 months for clinical outcomes and biomarker changes.
This study aims to develop a comprehensive biomarker-based prediction model to enhance the diagnosis and management of ischemic cerebrovascular disease.
Detailed Description:
The detaited information about this trial is described below
1. Quality assurance: The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
2. Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
3. Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists.
1. Quality assurance: The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
2. Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
3. Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: