Clinical trial NCT04912687: Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients
Official title: Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Advanced Solid Tumor
Keywords: non-small cell lung cancer
EGFR detection
liquid biopsy
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-06-03
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multicentric prospective cohort in which newly diagnosed advanced NSCLC patients will be included. For all patients, both tumor and liquid biopsy samples will be used for sequencing and detection of EGFR gene mutation
Primary purpose: SCREENING

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only
timeFrame: within 3 weeks after signature of informed consent
measure: The detection rate of patients with an EGFR actionable alteration based on tissue analysis only
timeFrame: within 3 weeks after signature of informed consent
measure: The concordance and discordance rates between the two procedures
timeFrame: within 3 weeks after signature of informed consent
measure: The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)
timeFrame: within 3 weeks after signature of informed consent
measure: Delay to obtain sequencing results
timeFrame: within 3 weeks after signature of informed consent
measure: Delay for treatment initiation
timeFrame: within 3 months after signature of informed consent
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest - Site Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nice
country: France
facility: CHU Nice-Hopital de Cimiel
city: Paris
country: France
facility: Institut Curie
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU de Rennes - Hopital Pontchaillou
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
References: