Clinical trial · Interventional
Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients
Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)
NCT04912687CI-TRIAL-00104865CIRCULARcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR gene mutation analysis on liquid biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- For all patients, blood sample will be collected at inclusion (liquid biopsy) for sequencing. As per standard management, for all of these patients, EGFR gene mutation will be also analyzed on archived tumor sample.
- interventionNames
- Diagnostic Test: EGFR gene mutation analysis on liquid biopsy
Primary outcomes (1)
- 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
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.