A Study of the Gene Mutation Status in Cerebrospinal Fluid, Blood and Tumor Tissue of Non-small Cell Lung Cancer Patients With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT03257735|
Recruitment Status : Unknown
Verified August 2017 by Li-kun Chen, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
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 treatment. So it is very important to determine the gene mutation status of the tumor and prescribe drugs at the targets. Liquid biopsy is a suitable alternative when tumor tissues are difficult to obtain. Liquid biopsy technique refers to the use of human body fluid as a sample source to detect the information of related diseases, including blood, urine, saliva and cerebrospinal fluid. It is non-invasive, fast and simple, and can avoid the problem of insufficient sample size and support for repeated sampling to continuously monitor disease.
With the increasing incidence of lung cancer and the development of diagnosis and treatment technology, the survival period of patients has been extended, and the incidence and diagnosis rate of the brain metastasis of lung cancer have increased year by year. The brain metastasis of lung cancer is the most common type of brain metastatic tumor. The incidence rate is about 40-50%, and the prognosis is poor——the natural median survival period is about 1-2 months. Because of the impractical intracranial tumor biopsy and very low level of DNA in peripheral blood, cerebrospinal fluid, which makes close contact with brain tumors, becomes potential available samples. Several studies have shown that genetic testing of cerebrospinal fluid is feasible. Therefore, this study aims to test the cerebrospinal fluid, blood and tissue by the latest second-generation sequencing technology at different time points, to dynamically monitor the gene mutation status of cerebrospinal fluid, blood and tissue, to explore the role of cerebrospinal fluid biopsy in the diagnosis and treatment of non-small cell lung cancer with brain metastases.
|Condition or disease||Intervention/treatment|
|Lung Cancer Brain Metastases Cerebrospinal Fluid Next-generation Sequencing||Diagnostic Test: next-generation sequencing|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||A Prospective and Observational Study of the Consistency of Gene Mutation Status Between Cerebrospinal Fluid, Blood and Tumor Tissue,and Correlation With Efficacy in Non-small Cell Lung Cancer Patients With Brain Metastases|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||May 31, 2019|
- Diagnostic Test: next-generation sequencing
- Patients' cerebrospinal fluid, blood and tumor tissue were collected within 3 days before treatment at diagnosis.
- Patients' cerebrospinal fluid and blood were extracted at the time of first evaluation of efficacy after treatment (TKI began after 1 month or chemotherapy after 2 cycles).
- Patients' cerebrospinal fluid and blood were extracted at first time of tumor progression，and re-biopsy of tumor tissue was done as much as possible.
All the samples were tested by next-generation sequencing.
- Change from baseline gene mutation status at 2 months [ Time Frame: 2 months ]compare the gene mutation status of cerebrospinal fluid,blood and tumor tissue at baseline and after the first session
- Change from second line gene mutation status at 6 months [ Time Frame: 6 months ]compare the gene mutation status of cerebrospinal fluid,blood and tumor tissue after the first session and at the time of tumor progression
- PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months. ]progression-free survival
- OS [ Time Frame: From date of randomization until the date of death from any cause,assessed up to 60 months ]overall survival
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257735
|Contact: Delan Li, firstname.lastname@example.org|
|Contact: Likun Chen, PhDemail@example.com|
|Principal Investigator:||Likun Chen, PhD||Sun Yat-sen University|