Risk and Prognosis of Brain Metastasis in Non-Small Cell Lung Cancer: A Multicenter, Prospective, Observational Study

Study Purpose

This multi-center, prospective, observational study aim to construct a comprehensive model, integrating common clinical pathological parameters, radiographic features and multi-omics data, for assessing the risk and prognosis of brain metastasis in NSCLC. This model is intended to address the following clinical needs:

(1) Identify patients at high risk of brain metastasis; (2) Optimize the combined strategies of local and systemic treatments; (3) Predict the survival outcomes of patients with brain metastases from NSCLC and provide evidence-based support for individualized treatment decisions.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Pathologically confirmed non-small cell lung cancer; - Age≥18 years old; - KPS score≥70; - Complete systemic imaging (including brain MRI) before treatment initiation, including contrast-enhanced MRI of the brain; - Receiving standard treatment; - Informed consent of the patient.

Exclusion Criteria:

- Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years); - Physical examination findings, clinical laboratory abnormalities, or other uncontrolled medical conditions identified by the investigator as potentially interfering with study results interpretation or increasing the patient's risk of - Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance; - Pregnant or lactating women.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07034365
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fudan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	NSCLC (Non-small Cell Lung Cancer), Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Arms & Interventions

Arms

: NSCLC patients receiving standard treatment

Interventions

Other: - No intervention

No intervention

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Zhengfei Zhu, PhD

[email protected]

+8618017312901

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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