BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting

The BEGIN Study, conducted by BostonGene and Exigent, is a prospective investigation aimed at evaluating the efficacy and feasibility of comprehensive molecular testing in advanced cancer patients within the community setting. Recent advancements in cancer treatment have led to the integration of targeted and immune-based therapies into standard practice. Recognizing the significance of genomic and molecular alterations in patient therapy selection, BostonGene has developed a high-throughput sequencing platform, the BostonGene Tumor Portrait test, which provides a comprehensive overview of tumors and their microenvironment.

The primary objectives of the study include determining the frequency of actionable findings identified by the BostonGene Tumor Portrait test, assessing the feasibility and turnaround time of comprehensive sequencing analysis, and evaluating the frequency of patient enrollment in clinical trials based on test results. Secondary objectives involve determining the frequency of patients receiving molecularly matched therapy, evaluating concordance between DNA and RNA targets, and assessing the impact of test findings on treatment decisions.

The study will involve four cohorts of patients with breast cancer, non-small cell lung cancer, melanoma, and sarcoma, each comprising 100 participants. Subjects will be identified through designated pilot sites. The study duration will be up to two years, with data collection including baseline demographics, medical history, treatment decisions, and patient outcomes.

Overall, the study aims to elucidate the clinical utility of the BostonGene Tumor Portrait test in guiding treatment decisions for advanced cancer patients in real-world community settings, with a focus on actionable findings, treatment efficacy, and patient outcomes.