Predictive Value of Exosomes in Pleural Effusion for Advanced Lung Cancer

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07262671

Acronym

MPE-NSCLC

Enrollment

100

Registered

2025-12-04

Start date

2025-10-16

Completion date

2030-10-16

Last updated

2025-12-04

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

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
objective response rate (ORR)	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.

Countries

China

Outcome results