Pleural Effusion Biomarkers in Lung Adenocarcinoma Patients

NCT07012759 — Recruiting, 100 participants, Fu Jen Catholic University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Novel Pleural Effusion Biomarkers Screening and Evaluation in Lung Adenocarcinoma Patients

RegistryNCT07012759
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorFu Jen Catholic University (Other)
ConditionsBiomarkers, Lung Adenocarcinoma, Pleural Effusion
Interventionsbiomarkers (Other)
Datesstart 2025-06-10, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-06-10, last updated 2026-03-05
Locations1 site in Taiwan

Related Papers Related Patents Related Grants Related Experts
All trials for Biomarkers All trials for Lung Adenocarcinoma All trials of biomarkers

-Summary

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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Case groupOther: biomarkersPatients with pleural effusion diagnosed as lung adenocarcinoma.
Control groupOther: biomarkersPatients with pleural effusion diagnosed as non-malignant.
  • biomarkers (Other): pleural effusion biomarkers in lung adenocarcinoma

+Outcome measures

Primary outcomes

  • target gene expression levels between malignant and non-malignant pleural effusions [20 minutes]: Novel biomarkers specifically expressed in malignant pleural effusions may provide additional diagnostic options for malignant lung cancer in clinical diagnosis

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Fu Jen Catholic University Hospital, Fu Jen Catholic UniversityNew Taipei CityTaiwanRecruiting

+Investigators