Pleural Effusion Biomarkers in Lung Adenocarcinoma Patients

March 4, 2026 updated by: Ke-Yun, Chao, Fu Jen Catholic University

Novel Pleural Effusion Biomarkers Screening and Evaluation in Lung Adenocarcinoma Patients

This project aims to assess the expression levels of novel molecular markers identified through screening in clinical samples of malignant pleural effusion, to evaluate the feasibility and clinical utility of these markers as potential diagnostic genes for lung adenocarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background： Pleural effusion is characterized by abnormal fluid accumulation within the pleural cavity. Patients with pleural effusion commonly present with symptoms such as thoracic tightness, dyspnea, cough, and thoracic pain. The etiology of pleural effusion is multifactorial, encompassing conditions such as tuberculosis infection, heart failure, autoimmune disorders, and malignancies. When cancer cells invade the pleural space, malignant pleural effusion occurs. Common primary sites of pleural effusion include the lungs, breasts, ovaries, and gastrointestinal tract. Hence, precise diagnosis and etiological determination are imperative for guiding therapeutic interventions and optimizing patient outcomes. Although the diagnosis of malignant pleural effusion predominantly relies on biomarkers, there remains scope for enhancing the sensitivity and specificity of traditional biomarkers.

Study Design： This study is a two-year, single-center, prospective case-control research Methods： The study plans to collect 100 cases of malignant and non-malignant pleural effusion samples from clinical patients. The molecular marker analysis will be performed on the supernatant and sedimented cells obtained through centrifugation. The investigator will compare the expression levels of marker genes previously identified in lung cancer cell models between malignant and non-malignant pleural effusion samples. The concentration of secretory proteins in the supernatant of pleural effusion will be analyzed using immunoblot assay, and the intracellular proteins will be analyzed using immunohistochemical staining.

Effect： Based on the experimental results, The investigator aim to identify novel diagnostic molecules for malignant pleural effusion and combine them with other diagnostic markers to enhance the sensitivity and specificity of clinical diagnosis.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24352
        • Recruiting
        • Fu Jen Catholic University Hospital, Fu Jen Catholic University
        • Contact:
        • Principal Investigator:
          • Ke-Yun Chao, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The control group consists of non-malignant pleural effusion, while the case group includes those diagnosed with pleural effusion with lung adenocarcinoma.

Description

Inclusion Criteria:

  • Patients requiring thoracentesis for pleural effusion drainage as determined by a physician based on clinical need.
  • Signed informed consent.

Exclusion Criteria:

  • Patients under the age of 18.
  • Patients with malignancies other than lung adenocarcinoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
Patients with pleural effusion diagnosed as lung adenocarcinoma.
Other: biomarkers
pleural effusion biomarkers in lung adenocarcinoma
Control group
Patients with pleural effusion diagnosed as non-malignant.
Other: biomarkers
pleural effusion biomarkers in lung adenocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target gene expression levels between malignant and non-malignant pleural effusions
Time Frame: 20 minutes
Novel biomarkers specifically expressed in malignant pleural effusions may provide additional diagnostic options for malignant lung cancer in clinical diagnosis
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University

Investigators

  • Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 1, 2025

First Submitted That Met QC Criteria

June 1, 2025

First Posted (Actual)

June 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH113386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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