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Clinical Application Research of Detecting Extracellular Vesicle RNA Based on Dual-Mode In-Situ Analysis System Combined with Machine Learning in Immunotherapy Evaluation of NSCLC

Clinical Application Research of Detecting Extracellular Vesicle RNA Based on Dual-Mode In-Situ Analysis System Combined with Machine Learning in Immunotherapy Evaluation of NSCLC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123507
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Non-Small Cell Lung Cancer

Interventions

Gold Standard:Reverse Transcription Quantitative Polymerase Chain Reaction(RT-qPCR)
Index test:EV-RNA detection method based on dual-modality in situ analysis system

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patient Inclusion Criteria:(1)Age >=18 years, male or female; (2)Voluntarily signed the informed consent form; (3)Medical records dated from January 1, 2024 to December 1, 2025; (4)Patients diagnosed with non-small cell lung cancer (NSCLC) in accordance with the 2025 CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer; (5)Receiving immunotherapy; (6)No mental illness and capable of normal understanding and communication. 2.Inclusion Criteria for Healthy Volunteers: (1)Aged >= 18 years, male or female; (2)Voluntarily signed the informed consent form; (3)Medical records dated from January 1, 2024 to December 1, 2025; (4)Normal individuals confirmed to be free of underlying diseases and tumors after examination at Nanfang Hospital, i.e., with normal liver function, normal electrocardiogram, and normal results of tumor markers and routine blood tests.

Exclusion criteria

Exclusion criteria: 1.Patient Exclusion Criteria:(1)Extensive systemic metastasis of the tumor; (2)Complicated with malignant tumors in other sites; (3)Severe organ dysfunction; (4)Expected survival time < 3 months; (5)Pregnant women; (6)Subjects with incomplete data or cases with incomplete collection due to other reasons; (7)Subjects judged by the investigator to be unsuitable for participation in this study. 2.Exclusion Criteria for Healthy Volunteers: (1)Subjects with incomplete data or cases for which data cannot be fully collected due to other reasons; (2)Pregnant women; (3)Subjects judged by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
To evaluate the clinical value of a new method combined with machine learning algorithm in the evaluation of immunotherapy for non-small cell lung cancer (NSCLC);—

Countries

China

Contacts

Public ContactZhang Ye

Southern Medical University Southern Hospital

Zhangye232@i.smu.edu.cn+86 20 61641044

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026