Clinical trial NCT06272864: BostonGene and Exigent Genomic INsight Study
Official title: BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Non-small Cell Lung Cancer
Melanoma
Sarcoma
Keywords: Comprehensive Molecular Testing
BostonGene Tumor Portrait Test
Molecularly Matched Therapy
DNA and RNA Targets
Lead sponsor: BostonGene
Sponsor class: INDUSTRY
Collaborators: name: Exigent
First posted: 2024-02-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced cancer patients

Brief 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.

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

Primary outcomes:
measure: Frequency of actionable findings
timeFrame: 2 years
measure: Test turn-around time
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of patients who receive molecularly matched therapy
timeFrame: 6 months
measure: Frequency of patients who receive molecularly matched therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Stockton
country: United States
facility: Stockton Hematology Oncology Medical Group
state: California
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Albuquerque
country: United States
facility: New Mexico Cancer Center
state: New Mexico
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Puyallup
country: United States
facility: Northwest Medical Specialities
state: Washington
Study officials:
References: