A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Using Next Generation Sequencing of Liquid Biopsy (POPCORN)

What this Trial Is About

This research aims to evaluate the real-world prevalence of clinically useful genetic mutations in patients with advanced or locally advanced solid tumors by using liquid biopsy and Next Generation Sequencing (NGS) techniques. NGS allows sequencing multiple genomes quickly from small genetic samples, detecting a wide range of genomic changes. The study focuses on identifying circulating biomarkers that may predict treatment sensitivity or resistance across various solid tumor types. Participants will have their blood tested through liquid biopsy to analyze circulating tumor DNA (ctDNA) using NGS methods. This observational study does not involve experimental treatments but collects genomic data to understand mutation patterns in patients receiving standard therapy for different advanced solid tumors, including colon-rectal, gastric, pancreatic, breast, ovarian, endometrial, cervical, vulva cancers, melanoma, and others. Throughout the study, participants will be monitored at four planned time points with assessments including genomic mutation analysis, clinical data collection, and correlation of genetic alterations with tumor features and patient outcomes such as progression-free and overall survival. The primary outcome is the prevalence of clinically useful mutations at treatment start. Secondary outcomes include identifying gene changes linked to survival and treatment response over up to seven years of follow-up.

A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)