Using blood tests to improve treatment for advanced lung cancer patients
Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)
NA · Institut Bergonié · NCT04912687
This study is testing if blood tests can help find specific gene changes in patients with advanced lung cancer to improve their treatment options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 580 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Bergonié (other) |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT04912687 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective cohort study aims to evaluate the detection rate of EGFR gene mutations in patients with advanced non-small cell lung cancer (NSCLC) using liquid biopsy and tissue analyses. Newly diagnosed patients will have both archived tumor tissue and blood samples collected for sequencing to determine their EGFR status. The study seeks to implement circulating tumor DNA analysis at the initial diagnosis to enhance management strategies for these patients. The samples will be processed in a Molecular Pathology laboratory to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced non-small cell lung carcinoma who have not received prior treatment.
Not a fit: Patients who have already started treatment for advanced NSCLC prior to liquid biopsy sampling will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with advanced NSCLC.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for detecting mutations in cancer patients, indicating that this approach is gaining traction in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Angers and 8 other locations
- Institut de Cancérologie de l'Ouest - Site Paul Papin — Angers, France (NOT_YET_RECRUITING)
- Institut Bergonie — Bordeaux, France (RECRUITING)
- CHRU Lille — Lille, France (NOT_YET_RECRUITING)
- Hospices Civils de Lyon — Lyon, France (RECRUITING)
- CHU Nice-Hopital de Cimiel — Nice, France (RECRUITING)
- Institut Curie — Paris, France (NOT_YET_RECRUITING)
- CHU Poitiers — Poitiers, France (NOT_YET_RECRUITING)
- CHU de Rennes - Hopital Pontchaillou — Rennes, France (RECRUITING)
- CHU Strasbourg — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Isabelle SOUBEYRAN, MD, PhD
- Email: i.soubeyran@bordeaux.unicancer.fr
- Phone: (0)5.56.33.33.33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non Small Cell Lung Cancer, Advanced Solid Tumor, non-small cell lung cancer, EGFR detection, liquid biopsy