Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346977
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-27
Brief Title:
Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC
Sponsor:
Organization:
Wuhan Union Hospital China
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITHOUT_DNA
Bio Spec Description:
In Part One of the study plasma samples 1 mL were collected from NLM group participants at the time of initial diagnosis when they presented with no clinical symptoms or radiological evidence of meningeal metastasis For LM group subjects both plasma 1 mL and cerebrospinal fluid 2 mL were obtained within two weeks prior to receiving intrathecal chemotherapy
In Part Two plasma and CSF were gathered from cohort subjects at three time points within two weeks before intrathecal chemotherapy baseline at T0 24 hours post-injection and at T28 28 days post-injection with 1 mL of plasma and 2 mL of CSF collected at each instance Plasma was acquired through venipuncture while CSF was extracted via lumbar puncture All collected samples were earmarked for proteomic analysis
Enrollment Count:
60
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Cohort |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 105534 |
Who Masked List: