Skip to main content
OpenTrials
Completed

NCT Number: NCT04912687

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non Small Cell Lung Cancer Advanced Solid Tumor Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers, France

Loading trial locations.

About this study

This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing).

Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

EGFR gene mutation analysis on liquid biopsy

Diagnostic Test

Blood samples will be collected at inclusion for plasma DNA collection and analysis.

Primary outcomes

  1. 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

    Time frame: within 3 weeks after signature of informed consent

    Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure

Secondary outcomes

  1. The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only

    Time frame: within 3 weeks after signature of informed consent

    A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by the liquid biopsy analysis if an EGFR actionable alteration is identified based on the liquid biopsy analysis

  2. The detection rate of patients with an EGFR actionable alteration based on tissue analysis only

    Time frame: within 3 weeks after signature of informed consent

    A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by tissue analysis if an EGFR actionable alteration is identified based on the sequencing of tumor tissue

  3. The concordance and discordance rates between the two procedures

    Time frame: within 3 weeks after signature of informed consent

    Concordance is defined whenever results of both techniques are identical (i.e. EGFR+ for both techniques or EGFR- for both techniques). Discordance is defined whenever results of both techniques are different.

  4. The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)

    Time frame: within 3 weeks after signature of informed consent

    •

    Failure of a procedure (sequencing of tumor tissue or liquid biopsy) is defined whenever the procedure fails to provide an interpretable result (Reasons for failure will be collected, i.e. insufficient DNA quantity, poor DNA quality, insufficient DNA/tissue quantity, poor DNA/tissue quality, analytical failure)

  5. Delay to obtain sequencing results

    Time frame: within 3 weeks after signature of informed consent

    The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure

  6. Delay for treatment initiation

    Time frame: within 3 months after signature of informed consent

    The delay between the date of sample collection and the date of treatment initiation

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)

Acronym: CIRCULAR

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.