Predictive Value of Exosomes in Pleural Effusion for Advanced Lung Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Cancer hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

objective response rate (ORR)

Time frame: From date of enrollment until the first documented progression or death from any cause, assessed up to 24 months.

Primary Objective: To investigate the association between baseline exLR expression profiles in plasma and malignant pleural effusion and the objective response rate (ORR) as assessed by RECIST 1.1 in patients with advanced NSCLC and MPE receiving systemic therapy.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Exosome Detection for Predicting Treatment Efficacy in Advanced NSCLC With Malignant Pleural Effusion

Acronym: MPE-NSCLC

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2030
First posted: Dec 4, 2025
Registry last updated: Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting