Predictive Value of Exosomes in Pleural Effusion for Advanced Lung Cancer

NCT07262671 | Active Not Recruiting

• 1 other identifier: MPE-NSCLC-2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  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.

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

Study Arms (1)

NSCLC-MPE

advanced NSCLC with Malignant Pleural Effusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll approximately 100-120 patients with histologically or cytologically confirmed stage IV NSCLC who present with MPE and are scheduled to receive standard systemic therapy (including but not limited to immunotherapy, chemotherapy, or targeted therapy).

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The following types of biospecimens will be collected and retained for research purposes in this study: Peripheral Blood: Approximately 8 mL of venous blood will be collected in EDTA anticoagulant tubes. Malignant Pleural Effusion (MPE): Approximately 4 mL of freshly drained pleural fluid will be collected.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jialei Wang, MD

  Shanghai Cancer hospital Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): October 16, 2027
• Study Completion (Estimated): October 16, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)