BostonGene and Exigent Genomic INsight Study (BEGIN)

February 21, 2024 updated by: BostonGene

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 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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Puyallup, Washington, United States, 98373
        • Northwest Medical Specialities
        • Contact:
          • Sibel Blau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Advanced cancer patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort 1 (Breast cancer)
patients with locally recurrent, unresectable or metastatic breast cancer
Cohort 2 (NSCLC)
patients with unresectable stage III or metastatic non-small cell lung cancer
Cohort 3 (Melanoma)
patients with unresectable or metastatic melanoma
Cohort 4 (Sarcoma)
patients with locally advanced or metastatic sarcoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of actionable findings
Time Frame: 2 years
the frequency of actionable findings identified by a comprehensive (WES/RNA) sequencing platform (BostonGene Tumor Portrait) in advanced cancer patients. Actionable findings will include: genomic findings such as fusions, single nucleotide variants (SNVs), insertion/deletion alterations (indels), copy number alterations (CNAs), tumor mutational burden (TMB), microsatellite instability (MSI), frameshifts, rearrangements, gene expression levels, genome instability and loss of heterozygosity, cell counts in TME, disease molecular type, inherited pathogenic mutations, mutational signatures, and gene isoform expression.
2 years
Test turn-around time
Time Frame: 2 years
the time from consent to biopsy (or archival tissue retrieval), time from receipt of biopsy to BostonGene Tumor Portrait testing results, and total time from consent to delivery of BostonGene Tumor Portrait testing resultsTumor Portrait testing
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of patients who receive molecularly matched therapy
Time Frame: 6 months
the frequency of patients who receive molecularly matched therapy within 6 months of undergoing genomic testing
6 months
Frequency of patients who receive molecularly matched therapy
Time Frame: 12 months
the frequency of patients who receive molecularly matched therapy within 12 months of undergoing genomic testing
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BostonGene

Collaborators

Exigent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 8, 2024

Primary Completion (Estimated)

January 8, 2026

Study Completion (Estimated)

January 8, 2028

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEGIN study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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