CompletedNot Applicable

Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients

France581 participantsStarted 2022-01-01

Plain-language summary

Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patients aged ≥ 18 years at time of proposal study,
✓. Histologically confirmed non-small cell lung carcinoma,
✓. No previous treatment for NSCLC,
✓. Indication to EGFR status determination following HAS recommendation,
✓. Voluntary signed and dated written informed consent prior to any study specific procedure
✓. Patients with a social security in compliance with the French Law.

Exclusion criteria

✕. Treatment for advanced NSCLC started before liquid biopsy sampling.
✕. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).

What they're measuring

To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis

Timeframe: within 3 weeks after signature of informed consent

Trial details

NCT IDNCT04912687

SponsorInstitut Bergonié

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-17

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