Risk and Prognosis of Brain Metastasis in Non-Small Cell Lung Cancer

NCT07034365 | Not Yet Recruiting

• 1 other identifier: LungBM2025
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

NSCLC (Non-small Cell Lung Cancer); Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Keywords

NSCLC; brain metastases; prognosis

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The time from enrollment to disease progression or death from any cause. Patients who were still alive at the time of analysis will have the date of their last contact as the cutoff date.

  2 years

Secondary Outcomes (2)

• Intracranial Progression-Free Survival (iPFS)

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

NSCLC patients receiving standard treatment

Other: No intervention

Interventions

No intervention OTHER

No intervention

NSCLC patients receiving standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are collected all over China, diagnosed with NSCLC.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples of the patient before and after standardized treatment, as well as baseline tissue samples of intracranial and extracranial lesions.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Zhengfei Zhu, PhD

CONTACT

+8618017312901; fuscczzf@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06