Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT03257735
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03257735
Study Brief:
Protocol Section:
NCT03257735