Lung Neoplasms Clinical Trial
— ctDNAOfficial title:
A Prospective, Observational Trial on the Diagnostic and Prognostic Value of Cell-free DNA in Advanced Lung Cancer With Leptomeningeal Metastases
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | August 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University of cancer center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Newman 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 Ma — View Citation
Pan 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | positive rate between the cell-free DNA and cytological examination of cerebrospinal fluid | 2 years | ||
Secondary | The relationship between the number of cell-free DNA and OS | 2 years |
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