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A Study of the Gene Mutation Status in Cerebrospinal Fluid, Blood and Tumor Tissue of Non-small Cell Lung Cancer Patients With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

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 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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Diagnostic Test: next-generation sequencing
    1. Patients' cerebrospinal fluid, blood and tumor tissue were collected within 3 days before treatment at diagnosis.
    2. 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).
    3. 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.

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. 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

  2. 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
We plan to detect the patients' cerebrospinal fluid,blood and tumor tissue with the method of next-generation sequencing.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were histologically confirmed with NSCLC and identified with new brain metastases by MRI.

Inclusion Criteria:

  1. Male or female, aged over 18 and less than 75 years old
  2. The estimated survival period is greater than 12 weeks
  3. ECOG score is less than 2
  4. Histological diagnosis is non-small cell lung cancer, and there are enough tissue specimens for lung cancer related gene detection
  5. The brain metastasis is confirmed by brain MRI, and the first line treatment of brain metastasis was considered as chemotherapy or target therapy
  6. 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)
  7. Patients are tolerable for lumbar puncture with no contraindication
  8. Patients are able to comply with the research requirements and follow-up procedures
  9. 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 Criteria:

  1. Brain metastases were treated
  2. Intracranial symptoms were obvious, and radiotherapy/surgery was considered in the first line treatment
  3. Histological specimens are not enough to detect lung cancer related genes
  4. Patients were suffering from other types of malignancy
  5. Patients have any contraindications of lumbar puncture
  6. 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
  7. Pregnant and lactating pregnant women
  8. Patients were not willing to be followed up

Information from the National Library of Medicine

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 identifier (NCT number): NCT03257735

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Contact: Delan Li, master 18676188892
Contact: Likun Chen, PhD 13798019964

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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Delan Li, master    18676188892   
Contact: Likun Chen, PhD    13798019964   
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Likun Chen, PhD Sun Yat-sen University
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Responsible Party: Li-kun Chen, Chief Physician, Sun Yat-sen University Identifier: NCT03257735    
Other Study ID Numbers: A2017-003
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data are not available to others.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases