184
Participants
Start Date
August 5, 2025
Primary Completion Date
October 8, 2027
Study Completion Date
August 7, 2029
FPG500
A cancer genome profiling with FPG500 will be performed on samples available from surgery or biopsy. Specimen are reviewed to assess tumor cell fraction. All H\&E slides are digitized before nucleic acid extraction. Semi-automated process is used for DNA/RNA extraction, DNA fragmentation, quantification, library preparation, and sequencing. Profiling is done with the TruSight Oncology 500 assay, analyzing 523 genes for single nucleotide variants, insertions/deletions, copy number variations, and fusions/splicing variants in 55 genes. It also evaluates genomic signatures like microsatellite instability and tumor mutational burden. Sequencing data are processed using Illumina software and a custom pipeline. Post-sequencing quality control is performed. Variants are classified according to the Human Genome Variation Society and clinical actionability guidelines. Genomic report is reviewed by an institutional Molecular Tumor Board.
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Urologia, Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER