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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 population

Patients are collected all over China, diagnosed with NSCLC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: NSCLC patients receiving standard treatment1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

Intracranial Progression-Free Survival (iPFS)

The time from the enrollment until the documentation of intracranial disease progression or death from any cause. If the patients have extracranial disease progression (without intracranial disease progression), the cutoff date was the date of the first occurrence of extracranial disease progression. Patients who have not progressed at the time of analysis will have their last contact date used as the cutoff date.

Time frame
2 years
2

Overall Survival (OS)

The time from the start of systemic treatment until death from any cause. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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