Lung CancerNCT03257735
A Study of the Gene Mutation Status in Cerebrospinal Fluid, Blood and Tumor Tissue of Non-small Cell Lung Cancer Patients With Brain Metastases
An observational study of Lung Cancer and Brain Metastases, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Brain Metastases, Cerebrospinal Fluid
- What is being tested?
- next-generation sequencing
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were histologically confirmed with NSCLC and identified with new brain metastases by MRI.
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Delan Li, master, 18676188892, lidl@sysucc.org.cn
Likun Chen, PhD, 13798019964, chenlk@sysucc.org.cn
About this study
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
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.
- Being tested
- next-generation sequencing
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
next-generation sequencingDiagnostic test
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline gene mutation status at 2 months
compare the gene mutation status of cerebrospinal fluid,blood and tumor tissue at baseline and after the first session
Measured: 2 months
Change from second line gene mutation status at 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
Measured: 6 months
Secondary outcomes (2)
PFS
progression-free survival
Measured: 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.
OS
overall survival
Measured: From date of randomization until the date of death from any cause,assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 May 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-kun Chen, Sun Yat-sen University
- Investigators
- Likun Chen, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257735
- Sponsor's protocol ID
- A2017-003
- Status last verified
- Aug 2017
- First submitted
- 5 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not available to others.
Publications
Li M, Chen J, Zhang B, Yu J, Wang N, Li D, Shao Y, Zhu D, Liang C, Ma Y, Ou Q, Hou X, Chen L. Dynamic monitoring of cerebrospinal fluid circulating tumor DNA to identify unique genetic profiles of brain metastatic tumors and better predict intracranial tumor responses in non-small cell lung cancer patients with brain metastases: a prospective cohort study (GASTO 1028). BMC Med. 2022 Nov 14;20(1):398. doi: 10.1186/s12916-022-02595-8.
PubMed 36372873
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03257735
- Acronym / sponsor ID
- A2017-003
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were histologically confirmed with NSCLC and identified with new brain metastases by MRI.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| next-generation sequencing1. 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. | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
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.
OS
Time frame: From date of randomization until the date of death from any cause,assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 36372873Li M, Chen J, Zhang B, Yu J, Wang N, Li D, Shao Y, Zhu D, Liang C, Ma Y, Ou Q, Hou X, Chen L. Dynamic monitoring of cerebrospinal fluid circulating tumor DNA to identify unique genetic profiles of brain metastatic tumors and better predict intracranial tumor responses in non-small cell lung cancer patients with brain metastases: a prospective cohort study (GASTO 1028). BMC Med. 2022 Nov 14;20(1):398. doi: 10.1186/s12916-022-02595-8.
- Individual participant dataSharing planned: No. Individual participant data are not available to others.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Likun Chen, PhD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Brain Metastases, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delan Li, master (18676188892, lidl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline gene mutation status at 2 months (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.