Genotyping of Ebus-tbna Supernant Cell-free Dna in Nsclc

Recruiting now

Conditions studied: Lung Cancer

In brief

The wide uptake of "liquid biopsy" diagnostics in the care of advanced cancer patients highlights the desire for improved access to tumor allowing accurate tumor genotyping (1). Genotyping of plasma cfDNA is now routine for detection of EGFR driver mutations at diagnosis of NSCLC, or for detection of the EGFR T790M mutation after TKI resistance, and is an emerging approach for the detection of other drivers (HER2 or BRAF mutations, ALK or ROS1 fusions…) (2) or the estimation of tumor mutation burden (TMB) (3). However, the most sensitive plasma genotyping platforms still have a sensitivity of only 70%-80%, such that a negative result requires tissue biopsy confirmation.

Key facts

Study ID

NCT04624373

Run by

University Hospital, Toulouse

People needed

50

Starts

2021-04-01

Expected to finish

2025-12-31

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years-old
• Patients planned for an EBUS-TBNA for
• Suspicion of stage IV lung cancer (PET+ mediastinal node(s)) (Cohort 1)
• Stage IV NSCLC with an EGFR, BRAF, HER2, MET mutation or ALK, RET or ROS1 rearranged NSCLC and acquired resistance to targeted therapy (Cohort 2)
• Performance status 0-3
• Informed consent

You may not qualify if…

• Refusal to participate
• Patient under legal tutelage

Where it is running

• Nicolas Guibert — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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