Status:
UNKNOWN
A Study of the Gene Mutation Status in Cerebrospinal Fluid, Blood and Tumor Tissue of Non-small Cell Lung Cancer Patients With Brain Metastases
Lead Sponsor:
Sun Yat-sen University
Conditions:
Lung Cancer
Brain Metastases
Eligibility:
All Genders
18-75 years
Brief Summary
Primary lung cancer is one of the most common malignancies in China, with 57 percent of patients being diagnosed at advanced stage. At present, advanced lung cancer has entered the era of precise trea...
Eligibility Criteria
Inclusion
- Male or female, aged over 18 and less than 75 years old
- The estimated survival period is greater than 12 weeks
- ECOG score is less than 2
- Histological diagnosis is non-small cell lung cancer, and there are enough tissue specimens for lung cancer related gene detection
- The brain metastasis is confirmed by brain MRI, and the first line treatment of brain metastasis was considered as chemotherapy or target therapy
- There must be at least one evaluable lesion based on the criteria of RECIST 1.1 (maximum diameter at least 10mm on spiral CT and MRI)
- Patients are tolerable for lumbar puncture with no contraindication
- Patients are able to comply with the research requirements and follow-up procedures
- Patients must sign the informed consent prior to the beginning of any substantive test procedure (informed consent is subject to approval of the independent ethics committee)
Exclusion
- Brain metastases were treated
- Intracranial symptoms were obvious, and radiotherapy/surgery was considered in the first line treatment
- Histological specimens are not enough to detect lung cancer related genes
- Patients were suffering from other types of malignancy
- Patients have any contraindications of lumbar puncture
- Patients have any uncontrolled systemic disease, including active infection, uncontrolled high blood pressure, diabetes, unstable angina and congestive heart failure, myocardial infarction (1 year) before the start of treatment, severe arrhythmia that needs drugs therapy, coagulant function abnormality, liver or kidney or metabolic disease
- Pregnant and lactating pregnant women
- Patients were not willing to be followed up
Key Trial Info
Start Date :
May 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03257735
Start Date
May 1 2017
End Date
May 31 2019
Last Update
August 22 2017
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000