Improving lung cancer detection using blood samples from bronchoscopy
Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules (Cancer Or Benign Endoscopy) (KOBE)
This study is testing whether analyzing blood samples taken during a lung procedure can help doctors better detect small lung cancer nodules in patients with uncertain diagnoses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse, Occitanie) |
| Trial ID | NCT05306912 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the sensitivity of radial endobronchial ultrasound (rEBUS) bronchoscopy for detecting malignant lung nodules smaller than 20 mm by analyzing cell-free DNA (cfDNA) methylation in supernatant samples collected during the procedure. The primary objective is to validate the effectiveness of a targeted 9-gene methylation analysis on cfDNA to improve diagnostic accuracy. Patients undergoing rEBUS for indeterminate nodules will have blood samples taken, and the cfDNA will be extracted and analyzed for methylation patterns. The study will follow participants for one year to correlate findings with final diagnoses.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for rEBUS bronchoscopy with one to three lung nodules smaller than 20 mm.
Not a fit: Patients with a prior lung cancer diagnosis or those with mediastinal or extra thoracic lesions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate detection of early-stage lung cancer, improving patient outcomes.
How similar studies have performed: While the use of cfDNA analysis is established, this specific approach of using supernatant from rEBUS specimens is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * rEBUS bronchoscopy planned for one, two or three ≤ 20 mm nodule * World Health Organization (WHO) Performance status 0-3 * Informed signed consent * Patient affiliated or beneficiary of a social security scheme (Social Security or Universal Medical Coverage). Exclusion Criteria: * Lung cancer diagnosed before the date of the procedure * Lung cancer strongly suspected due to mediastinal or extra thoracic lesions * Patient under State Medical Assistance * Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice
Where this trial is running
Toulouse, Occitanie
- Toulouse University Hospital — Toulouse, Occitanie, France (Recruiting)
Study contacts
- Principal investigator: Valentin HELUAIN, MD — University Hospital, Toulouse
- Study coordinator: Valentin HELUAIN, MD
- Email: heluain.v@chu-toulouse.fr
- Phone: +33567771439
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.