NCT04624373 Genotyping of Ebus-tbna Supernant Cell-free Dna in Nsclc
| NCT ID | NCT04624373 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-04-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years-old * Patients planned for an EBUS-TBNA for 1. Suspicion of stage IV lung cancer (PET+ mediastinal node(s)) (Cohort 1) 2. 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 Exclusion Criteria: * Refusal to participate * Patient under legal tutelage
Contact & Investigator
Nicolas Guibert
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT04624373 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04624373 currently recruiting?
Yes, NCT04624373 is actively recruiting participants. Contact the research team at guibert.n@chu-toulouse.fr for enrollment information.
Where is the NCT04624373 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT04624373 clinical trial?
NCT04624373 is sponsored by University Hospital, Toulouse. The principal investigator is Nicolas Guibert at University Hospital, Toulouse. The trial plans to enroll 50 participants.
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