BostonGene and Exigent Genomic INsight Study

Breast Cancer Clinical Trial

— BEGIN  

Official title:

BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272864
• Other study ID #: BEGIN study
• Status: Not yet recruiting
• Start date: March 8, 2024
• Est. completion date: January 8, 2028

Study information

• Verified date: February 2024
• Source: BostonGene
• Contact: Zhanna SHekhovtsova
• Phone: +37455887591
• Email: zhanna.shekhovtsova[@]bostongene.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 8, 2028
• Est. primary completion date: January 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Melanoma
• Non-small Cell Lung Cancer
• Sarcoma

Locations

Country	Name	City	State
United States	Northwest Medical Specialities	Puyallup	Washington

Sponsors (2)

Lead Sponsor	Collaborator
BostonGene	Exigent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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	2 years
Secondary	Frequency of patients who receive molecularly matched therapy	the frequency of patients who receive molecularly matched therapy within 6 months of undergoing genomic testing	6 months
Secondary	Frequency of patients who receive molecularly matched therapy	the frequency of patients who receive molecularly matched therapy within 12 months of undergoing genomic testing	12 months