Skip to content

Dynamic Monitoring of Molecular Markers in Response to Brain Metastasis Treatment of Lung Adenocarcinoma: A Prospective Clinical Study Based on EV Surface Protein Enrichment and ddPCR Absolute Quantification

Dynamic Monitoring of Molecular Markers in Response to Brain Metastasis Treatment of Lung Adenocarcinoma: A Prospective Clinical Study Based on EV Surface Protein Enrichment and ddPCR Absolute Quantification

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111023
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-10-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the lung with brain metastases

Interventions

LUAD-BM group:None
Control group:None

Sponsors

Tianjin Huanhu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: LUAD-BM group 1. Pathological diagnosis Specimens from bronchoscopic biopsy, lung biopsy or surgical resection were confirmed as lung adenocarcinoma by histopathology or cytology (based on the 2021WHO Lung Tumor classification criteria), and other types such as small cell lung cancer and squamous cell carcinoma were excluded. If it is A biopsy of metastatic lesions (such as surgical specimens of brain metastases), the evidence of the primary lesion of lung adenocarcinoma must be met simultaneously (such as previous history of lung adenocarcinoma + immunohistochemical consistency: TTF-1(+), Napsin A(+)). 2. Confirmed diagnosis of brain metastasis Enhanced cranial MRI (including T1-weighted enhancement, T2-weighted, and FLAIR sequences) shows the presence of >=1 measurable metastatic focus (with the longest diameter = 5mm) in the brain, and it meets one of the following characteristics: New brain metastases (first discovered, without any brain treatment); Previous brain metastases that progressed after treatment (judged as PD according to RECIST v1.1 criteria) require re-treatment with gamma knife; Exclude meningeal metastasis (positive cerebrospinal fluid cytology or meningeal enhancement on MRI, but no clear brain parenchymal metastasis). 3. The treatment plan is clear Intended to receive gamma knife treatment, and the treatment plan meets the following criteria: Single treatment: Tumor margin dose 15-20 Gy; Fractional treatment: The total dose is 20-30 Gy, completed in 2-3 fractions. No radiotherapy to the brain (including whole brain radiotherapy and stereotactic radiotherapy) or brain surgery (such as resection of metastatic lesions) was received before treatment. 4. The clinical status meets the standards Age: 18-80 years old (calculated from the date of signing the informed consent form); ECOG physical condition score: 0-2 points (Specifically: 0 points = completely normal activity ability, 1 point = able to walk freely and engage in light physical activities, 2 points = able to walk freely and take care of oneself, but unable to work). The expected survival period is >= 6 months (independently evaluated by 2 attending physicians, with a consistent conclusion taken). 5. The laboratory inspection is qualified Blood routine: Platelet count (PLT) >= 100×10^9/L, absolute neutrophil count (ANC) >=1.5×10^9/L; Liver and kidney function: ALT and AST =60 mL/min (calculated by Cockcroft-Gault formula); Coagulation function: International normalized ratio (INR) <= 1.5, activated partial thromboplastin time (APTT) <= 1.2×ULN. 6. Informed consent The patient or their legal representative fully understands the research content, voluntarily signs the written informed consent form, and can cooperate to complete the sample collection and 12-month follow-up. Control group Pathological diagnosis: Pathologically confirmed as a primary central nervous system tumor through surgery or biopsy, and meeting one of the following types (based on the 2021WHO Classification of Central Nervous System Tumors) : Meningioma (WHO grade I, no malignant transformation); Low-grade gliomas (WHO grade II, such as astrocytoma and oligodendroglioma); High-grade gliomas (WHO grade III-IV, which may release tumor-like EVs due to high malignancy) are excluded. 2. Clinical status: Aged 18 to 80; ECOG score: 0-2 po

Exclusion criteria

Exclusion criteria: LUAD-BM group 1. Tumor-related exclusion Combined with other primary malignant tumors (excluding non-melanoma skin cancer and cervical carcinoma in situ); There is spinal cord metastasis or other extracranial metastasis (such as liver or bone metastasis) and it is in the progressive stage (the lesion has increased by >= 20% in the past 3 months). 2. Treatment-related exclusion Previously received brain radiotherapy (such as whole-brain radiotherapy dose >=30 Gy) or brain surgery (such as resection of metastatic lesions); There are contraindications for gamma knife treatment. 3. Exclusion of complications Severe cardiovascular disease: New York Heart Association (NYHA) cardiac function classification > or = grade III, or myocardial infarction occurred within the last 6 months, or severe arrhythmia (such as atrial fibrillation with ventricular rate > 100 beats per minute); Active infections: such as uncontrolled pneumonia (body temperature > 38.5 ? and blood routine indicating infection), active tuberculosis (PPD positive + chest CT showing active lesions), HIV infection (CD4?T cells < 200/µL); Coagulation dysfunction: PLT < 80×10^9/L, or there is an uncontrolled bleeding tendency (such as gastrointestinal bleeding within the last month); Mental or cognitive impairment: A score of less than 24 on the Mini-Mental State Examination (MMSE) (indicating impaired cognitive function and inability to cooperate with follow-up). 4. Exclusion related to sample collection Extremely poor vascular conditions (such as peripheral veins being unable to be punctured for blood collection); Allergic to EDTA anticoagulants, magnetic beads or PCR reagent components (with a clear history of allergy in the past); Received blood transfusion or blood products within 24 hours before enrollment (which may interfere with EV detection). Control group 1. Comply with the "Exclusion of comorbidities" and "Exclusion related to sample collection" clauses in the exclusion criteria of the LUAD-BM group; 2. There is a family history of lung cancer (if a first-degree relative has lung cancer, there may be genetic background interference).

Design outcomes

Primary

MeasureTime frame
Surface proteins and intracellular mRNA of extracellular vesicles (EVs);

Countries

China

Contacts

Public ContactXiaomin Liu

Tianjin Huanhu Hospital

liuxiaomintj@126.com+86 22 5906 5693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026