Skip to content

Exploratory Study on the Dynamic Changes of Cerebrospinal Fluid Micro-Protein Profiles and Their Diagnostic Value for Central Nervous System Infiltration in Hematologic Diseases

Exploratory Study on the Dynamic Changes of Cerebrospinal Fluid Micro-Protein Profiles and Their Diagnostic Value for Central Nervous System Infiltration in Hematologic Diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124722
Enrollment
Unknown
Registered
2026-05-15
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic malignancies

Interventions

Gold Standard:1. Central nervous system signs, especially increased intracranial pressure
2. CSF changes: (1) Intracranial pressure > 200 mmH2O
(2) WBC > 0.01 × 10^9/L
(3) leukemia cells on smear
(4) protein > 0.45 g/L or positive qualitative test
3. Other causes of similar CNS or CSF changes excluded.
Index test:Cerebrospinal fluid cytokine levels, indicators including: IL-1ß, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-a, IFN-?, IFN-a, IL-12p70, IL-17.

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of hematologic malignancy; 2. Requirement for cerebrospinal fluid (CSF) collection based on clinical indications.

Exclusion criteria

Exclusion criteria: 1. Non-lymphoid related nervous system tumors; 2. Central nervous system diseases of immune, infectious, or traumatic origin.

Design outcomes

Primary

MeasureTime frame
Cerebrospinal fluid cytokines (IL-1ß, IL-2, etc.);sensitivity;specificity;

Secondary

MeasureTime frame
Quantitative analysis of cerebrospinal fluid protein;Cerebrospinal fluid abnormal cell ratio;Cerebrospinal fluid glucose;cerebrospinal fluid chloride;Flow cytometry immunophenotyping;Cerebrospinal fluid white blood cell count;Chromosome karyotyping;Receiver operating characteristic curve (ROC);Fusion gene;Morphological analysis of bone marrow smear cells;

Countries

China

Contacts

Public ContactXia Peng

Shanghai General Hospital

pengxiajiao1@163.com+86 21 63240090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026