Official Title
Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis
Brief Title
Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis
Protocol ID
NCT03029065
Lead Sponsor
Shandong Cancer Hospital and Institute
Brief Summary
This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma,
and to determine whether cfDNA can be used for concomitant diagnosis to improve the
treatment efficacy and prognosis of patients with brain (meningeal) metastasis by
monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal
fluid.
Detailed Description
This study planned to enroll 50 patients with lung cancer diagnosed with brain
(meningeal) metastases, and all cases were slated to receive radiotherapy and targeted
therapy. Patients' clinical data were collected (including but not limited to: age at
diagnosis with brain (meningeal) metastases, KPS score, smoking history, stage of disease
at diagnosis, time to progress to brain metastases, number of brain metastases,
extracranial metastases (ECM), and systemic disease at the time of brain metastases.
Anticoagulated whole blood and anticoagulated cerebrospinal fluid were collected before
local treatment (samples of primary cancer tissue and metastatic carcinoma of some
patients were preserved) and at 7 days, 1 month, 3 months, as well as 6 months after the
treatment (time of sample retention was to be determined, Figure 2). DNA was extracted
from tumor tissues, genomic DNA was extracted from leukocytes, and cfDNA was extracted
from plasma and cerebrospinal fluid, for complete quantitative detection of DNA, DNA
library construction, as well as targeted capture sequencing. Tumor-related genes were
analyzed, and changes in the tumor burden during the treatment process were evaluated.
The clinical significance of cfDNA in the plasma and cerebrospinal fluid for treatment
efficacy and prognosis was evaluated, and compared with that of clinical indicators of
treatment efficacy.
This study involved two stages. The first stage was a pre-experiment: samples were
retained from 3-5 cases, and mutations in tumor-related genes in the cfDNA in plasma and
cerebrospinal fluid were compared. The investigators analyzed, combined with clinical
indicators, whether mutations of cfDNA in plasma accord with that of the cerebrospinal
fluid and whether mutations of cfDNA in cerebrospinal can reflect the mutational status
of tumor cells. The second phase was conducted by expanding the number of cases, based on
the first stage.
Enrollment Count
50 participants
Eligibility Criteria
Inclusion Criteria:
1. Patients with confirmed diagnosis of lung adenocarcinoma with brain (meningeal)
metastasis.
2. Samples collection should be allowed.
Exclusion Criteria:
1. Pregnant women
2. Minors (subjects less than 18 years of age)
Filters
Recruitment
UNKNOWN
ADULT
OLDER_ADULT