跳至主要内容
临床试验/NCT07012759
NCT07012759招募中不适用

Novel Pleural Effusion Biomarkers Screening and Evaluation in Lung Adenocarcinoma Patients

Fu Jen Catholic University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
target gene expression levels between malignant and non-malignant pleural effusions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Case group

Patients with pleural effusion diagnosed as lung adenocarcinoma.

干预措施: biomarkers (Other)

Control group

Patients with pleural effusion diagnosed as non-malignant.

干预措施: biomarkers (Other)

结局指标

主要结局

target gene expression levels between malignant and non-malignant pleural effusions

时间窗: 20 minutes

Novel biomarkers specifically expressed in malignant pleural effusions may provide additional diagnostic options for malignant lung cancer in clinical diagnosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Assistant Professor

Fu Jen Catholic University

研究点 (1)

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