Pleural fluid biomarker testing to help diagnose lung adenocarcinoma
Novel Pleural Effusion Biomarkers Screening and Evaluation in Lung Adenocarcinoma Patients
This project will test whether measuring new molecular markers in pleural fluid can help diagnose lung adenocarcinoma in adults who need thoracentesis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fu Jen Catholic University Academic / other |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT07012759 on ClinicalTrials.gov |
What this trial studies
This is a two-year, single-center prospective case-control study conducted at Fu Jen Catholic University Hospital. The investigators will collect about 100 pleural effusion samples from patients with malignant and non-malignant causes who undergo clinically indicated thoracentesis. After centrifugation, both the supernatant and the sedimented cells will be analyzed for expression of candidate genes and concentrations of secreted proteins previously identified in lung cancer cell models. Expression levels will be compared between malignant and non-malignant samples to determine whether the markers can distinguish lung adenocarcinoma-related effusions.
Who should consider this trial
Good fit: Adults who require thoracentesis for pleural effusion and who consent to provide samples, particularly those with suspected or confirmed lung adenocarcinoma, are ideal candidates.
Not a fit: Patients under 18, people with pleural effusions caused by cancers other than lung adenocarcinoma, and individuals not undergoing thoracentesis are unlikely to receive direct benefit from this observational biomarker study.
Why it matters
Potential benefit: If successful, these biomarkers could enable more accurate, less invasive diagnosis of lung adenocarcinoma from pleural fluid and reduce the need for additional invasive procedures.
How similar studies have performed: Prior biomarker studies on pleural fluid have shown promise for improving diagnosis but many candidate markers remain unvalidated in clinical samples, so this effort builds on preliminary findings rather than established clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Taipei City
- Fu Jen Catholic University Hospital, Fu Jen Catholic University — New Taipei City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ke-Yun Chao, PhD — Fu Jen Catholic University
- Study coordinator: Ke-Yun Chao, PhD
- Email: ck_qq@hotmail.com
- Phone: +886905301879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.