Predictive Value of Exosomes in Pleural Effusion for Advanced Lung Cancer

NCT ID: NCT07262671

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-16

Study Completion Date

2030-10-16

Brief Summary

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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.

Detailed Description

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Conditions

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NSCLC (Advanced Non-small Cell Lung Cancer)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NSCLC-MPE

advanced NSCLC with Malignant Pleural Effusion

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Jialei Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jialei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Cancer hospital Fudan University

Locations

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Shanghai Cancer hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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MPE-NSCLC-2025

Identifier Type: -

Identifier Source: org_study_id

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