Table 2.
Clinical trials regarding circulating cell-free DNA/circulating tumor DNA in lung cancer.
| Name/NTC | Status | Condition/Patients (n) | Brief Summary |
|---|---|---|---|
| Europe-Japan Diagnostic Study for EGFR Testing (ASSESS) NCT01785888 |
Completed (2016) |
Stage IIIA/B or metastatic NSCLC n = 1311 |
To assess the concordance of EGFR mutation status derived from tumor samples and blood-based cfDNA. |
| T790M Mutation on ctDNA in Patients with NSCLC After EGFR-TKI Failure NCT02418234 |
Completed (2018) |
Metastatic/stage III NSCLC n = 314 |
To compare the frequency and abundance of T90M mutation using ARMS and ddPCR among different clinical modes of NSCLC patients with EGFR-TKI failure. |
| Study to Evaluate Concordance of Detecting EGFR Mutation by Circulating Tumor Free DNA Versus Tissues Biopsy in NSCLC. NCT03562819 |
Completed (2019) |
Adenocarcinoma n = 269 |
To assess EGFR mutation status by circulation tumor free DNA in advanced NSCLC patients comparing to adenocarcinoma histology. |
| LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer (LIBIL) NCT02511288 |
Recruiting | Stage IIIB/IV NSCLC n = 900 |
To characterize the genetic profile of patients with advanced stage NSCLC through ctDNA using ddPCR and targeted NGF, whole genome sequencing. |
| Evaluation of the Feasibility and Clinical Relevance of Liquid Biopsy in Patients with Suspicious Metastatic Lung Cancer (LIBELULE) NCT03721120 |
Recruiting | Metastatic LCa n= 286 |
To perform genomic analyses of cfDNA using the InVision® technology, by profiling the presence of genomic aberrations in a panel of 35 genes, including all actionable alterations required to initiate the appropriate first-line therapy (EGFR, ALK, ROS1, and BRAF V600E). |
| TR(ACE) Assay Clinical Specimen Study NCT02934360 |
Unknown | NSCLC n = 450 |
To evaluate the TR(ACE) Assay as a method of diagnostic, monitoring disease progress and response to therapy. This assay is a quantitative in vitro diagnostic test run in the TR(ACE) instrument that uses an electrokinetic technique to selectively capture cfDNA and others cellular debris directly from a blood sample. |
Information collected from www.clinicatrials.gov, accessed on 5 January 2021. Abbreviations: cfDNA—circulating cell-free DNA; ctDNA—circulating tumor DNA; ARMS—amplification refractory mutation system; ddPCR—digital droplet PCR; EGFR—epidermal growth factor receptor; LCa—lung cancer; NSCLC—non-small cell lung cancer; TKIs—tyrosine kinase inhibitors.