RecruitingNot Applicable

Molecular Analysis of Endoscopic Cytology Samples Supernatant in Pulmonary Nodules

France60 participantsStarted 2022-04-08

Plain-language summary

Lung cancer screening is based on low dose CT scan (LDCT), a highly sensitive but poorly specific tool. Complementary specific approaches are thus strongly needed, among which cell-free DNA (cfDNA) genotyping has been proven highly specific but of low sensitivity (25 to 50% for stage I diseases) due to inconstant tumor shed. Tumor biopsy is thus often required and radial endobronchial ultrasound (rEBUS) bronchoscopy is a minimally invasive approach (\<3% complications) but of limited sensitivity in cases of nodules \< 20 mm. The investigators hypothesized that methylation analysis on cfDNA floating in supernatant derived from rEBUS specimens could improve rEBUS sensitivity

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfDNA to detect a malignant nodule will be evaluated.

Timeframe: 1st day (D0) of patients' inclusion, on morning of their ultrasound-bronchoscopy

Trial details

NCT IDNCT05306912

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Valentin HELUAIN, MD

+33567771439 heluain.v@chu-toulouse.fr

View on ClinicalTrials.gov More Lung Cancer trials