Health TrialsbyHealthPanel

BostonGene and Exigent Genomic INsight Study

ConditionsBreast CancerNon-small Cell Lung CancerMelanomaSarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBostonGene

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

not meeting the inclusion criteria

Trial population

Advanced cancer patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 4 trial groups
Group A: Breast cancer
Group B: NSCLC
Group C: Melanoma
Group D: Sarcoma

Trial outcomes

Primary outcomes

1

Frequency of actionable findings

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.

Time frame
2 years
2

Test turn-around time

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

Time frame
2 years

Secondary outcomes

1

Frequency of patients who receive molecularly matched therapy

the frequency of patients who receive molecularly matched therapy within 6 months of undergoing genomic testing

Time frame
6 months
2

Frequency of patients who receive molecularly matched therapy

the frequency of patients who receive molecularly matched therapy within 12 months of undergoing genomic testing

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BostonGene

Lead sponsor

Exigent

Collaborator

Source ClinicalTrials.gov
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