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Trial Title:
BostonGene and Exigent Genomic INsight Study
NCT ID:
NCT06272864
Condition:
Breast Cancer
Non-small Cell Lung Cancer
Melanoma
Sarcoma
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Sarcoma
Conditions: Keywords:
Comprehensive Molecular Testing
BostonGene Tumor Portrait Test
Molecularly Matched Therapy
DNA and RNA Targets
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Advanced cancer patients
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwest Medical Specialities
Address:
City:
Puyallup
Zip:
98373
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sibel Blau, MD
Start date:
April 8, 2024
Completion date:
January 8, 2028
Lead sponsor:
Agency:
BostonGene
Agency class:
Industry
Collaborator:
Agency:
Exigent
Agency class:
Other
Source:
BostonGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06272864
