Clinical trial · Observational
A Prospective, Observational Trial on the Diagnostic and Prognostic of LM
A Prospective, Observational Trial on the Diagnostic and Prognostic Value of Cell-free DNA in Advanced Lung Cancer With Leptomeningeal Metastases
NCT02607605CI-TRIAL-00030072ctDNAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this study is to compare the positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid in Advanced lung cancer with leptomeningeal metastases.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Meningeal Carcinomatosis | Meningeal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- The relationship between the number of cell-free DNA and OS
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient who was confirmed primary lung cancer by pathologic histology or cytology 2. Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1.Life expectancy of at least 12 weeks. 3. Clinical symptoms and imaging tests are highly suspicious of advanced lung cancer with leptomeningeal metastases 4. Without contraindications to lumbar puncture Exclusion Criteria: 1. Patients who have primary benign or malignant brain tumor and metastatic malignant brain tumor 2. Patients who have contraindications to lumbar puncture 3. Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease
References
Publications (2)
- RESULTPan W, Gu W, Nagpal S, Gephart MH, Quake SR. Brain tumor mutations detected in cerebral spinal fluid. Clin Chem. 2015 Mar;61(3):514-22. doi: 10.1373/clinchem.2014.235457. Epub 2015 Jan 20. PMID 25605683
- RESULTNewman AM, Bratman SV, To J, Wynne JF, Eclov NC, Modlin LA, Liu CL, Neal JW, Wakelee HA, Merritt RE, Shrager JB, Loo BW Jr, Alizadeh AA, Diehn M. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med. 2014 May;20(5):548-54. doi: 10.1038/nm.3519. Epub 2014 Apr 6. PMID 24705333