BostonGene and Exigent Genomic INsight Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Non-small Cell Lung Cancer, Melanoma, Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting
Overview
The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings.
Detailed description
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.
Primary outcome measures
- Frequency of actionable findings [Time frame: 2 years]
- Test turn-around time [Time frame: 2 years]
Secondary outcome measures (2)
- Frequency of patients who receive molecularly matched therapy [Time frame: 6 months]
- Frequency of patients who receive molecularly matched therapy [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Highlands Oncology Group — Rogers
- Stockton Hematology Oncology Medical Group — Stockton
- Fort Wayne Medical Oncology and Hematology — Fort Wayne
- New Mexico Cancer Center — Albuquerque
- Oklahoma Cancer Specialists and Research Institute — Tulsa
- Oncology Consultants — Houston
- Northwest Medical Specialities — Puyallup
Identifiers
NCT: NCT06272864 · BEGIN study