Skip to content

Clinical study of artificial intelligence aided diagnosis on cellular morphology of cerebrospinal fluid in Leptomeningeal cancer

Clinical study of artificial intelligence aided diagnosis on cellular morphology of cerebrospinal fluid in Leptomeningeal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036595
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Leptomeningeal cancer

Interventions

Gold Standard:1. pathology of primary lesion of tumor 2. Immunohistochemical staining of cerebrospinal fluid cytology 3. Flow cytometry for cerebrospinal fluid 4. High clinically suspect of condition
detection&#32
model&#32
based&#32
on&#32
deep&#32
neural&#32
and&#32
diagnosis&#32

Sponsors

Huashan Hospital North, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. Patients who have indications for lumbar puncture and successfully completed the assay of cerebrospinal fluid cytology; 3. With or without more than one symptom of Leptomeningeal cancer, such as headache, vomiting, mental state change, cognitive impairment, seizures, hemiplegia, gait instability, etc., indicating clinically conditions of leptomeningeal cancer; 4. Clinical conditions of infectious meningitis (bacterial, viral, tuberculosis, etc.); 5. Clinical conditions of immune-mediated non-infectious encephalomyelitis; 6. Increased cerebrospinal fluid cells due to unknown reasons.

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to sign informed consent; 2. Patients who cannot tolerate lumbar puncture; 3. Patients who have failed multiple lumbar punctures; 4. Patients who have conditions of leptomeningeal cancer after treatment with radiotherapy and chemotherapy; 5. Without immunohistochemistry, flow cytometry, or biopsy pathology, leptomeningeal cancer cannot be ruled out; 6. The quality of cerebrospinal fluid cytology smear is not up to standard; 7. The cerebrospinal fluid cell count is lower than 5/µL.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy;SEN, SPE, AUC of ROC;

Countries

China

Contacts

Public ContactMing Guan

Huashan Hospital North, Fudan University

guanming88@126.com+86 13311919163

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026