Predictive Value of Exosomes in Pleural Effusion for Advanced Lung Cancer (MPE-NSCLC)

Fudan University

Status: Active, not recruiting

Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)

Study type: Observational

Funder types: Other

Identifiers

NCT07262671

MPE-NSCLC-2025

Details and patient eligibility

About

The goal of this observational study is to investigate the predictive value of exosome characteristics in patients with advanced non-small cell lung cancer (NSCLC) and malignant pleural effusion (MPE). The main question it aims to answer is:

Can the long RNA profile of exosomes derived from plasma and malignant pleural effusion predict treatment response in patients with advanced NSCLC and MPE? Participants who are scheduled to receive standard systemic therapy (including immunotherapy, chemotherapy, or targeted therapy) as part of their regular medical care will be enrolled. Researchers will collect paired samples of peripheral blood and malignant pleural effusion at baseline and key time points during treatment to analyze the exosomal long RNA profiles and correlate them with treatment efficacy and survival outcomes.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Confirmed advanced-NSCLC Aged 18-75 years. ECOG performance status of 0-1. At least one measurable lesion as per RECIST 1.1. Adequate bone marrow, liver, and renal function. Willing and able to provide written informed consent.

Exclusion criteria

- Mixed small cell lung cancer histology. Symptomatic or untreated brain metastases. Uncontrolled cardiovascular diseases or severe comorbidities. Active hepatitis B/C or HIV infection.

Trial design

100 participants in 1 patient group

NSCLC-MPE

Description:

advanced NSCLC with Malignant Pleural Effusion