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BostonGene and Exigent Genomic INsight Study

NCT06272864 · BostonGene
In plain English

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Official title
BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting
About this study
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.
Eligibility criteria
Inclusion Criteria: * Patients must have a confirmed malignancy of: Locally recurrent, unresectable, or metastatic breast cancer or; Unresectable stage III or metastatic non-small cell lung cancer or; Unresectable or metastatic melanoma or; Locally advanced or metastatic l sarcoma. * Life expectancy \> 3 months as per the treating physician * Willingness to provide informed consent * Living in the United States at time of enrollment * Agree to participate in genomic and molecular profiling Exclusion Criteria: * not meeting the inclusion criteria
Study design
Enrollment target: 400 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-04-08
Estimated completion: 2028-01-08
Last updated: 2025-02-17
Primary outcomes
  • Frequency of actionable findings (2 years)
  • Test turn-around time (2 years)
Sponsor
BostonGene · industry
With: Exigent
Contacts & investigators
ContactRheanna Carter, MBA · contact · rheanna.carter@bostongene.com · 650-773-0771
All locations (7)
Highlands Oncology GroupRecruiting
Rogers, Arkansas, United States
Stockton Hematology Oncology Medical GroupRecruiting
Stockton, California, United States
Fort Wayne Medical Oncology and HematologyRecruiting
Fort Wayne, Indiana, United States
New Mexico Cancer CenterRecruiting
Albuquerque, New Mexico, United States
Oklahoma Cancer Specialists and Research InstituteRecruiting
Tulsa, Oklahoma, United States
Oncology ConsultantsRecruiting
Houston, Texas, United States
Northwest Medical SpecialitiesRecruiting
Puyallup, Washington, United States