BostonGene and Exigent Genomic INsight Study

NCT06272864 | Recruiting

• 1 other identifier: BEGIN study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Frequency of patients who receive molecularly matched therapy

  6 months

• Frequency of patients who receive molecularly matched therapy

  12 months

Study Arms (4)

Breast cancer

Patients with locally recurrent, unresectable or metastatic breast cancer

NSCLC

Patients with unresectable stage III or metastatic non-small cell lung cancer

Melanoma

Patients with unresectable or metastatic melanoma

Sarcoma

Patients with locally advanced or metastatic sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced cancer patients

You may qualify if:

• 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

Sponsors & Collaborators

• BostonGene: lead
• Exigent: collaborator

Study Sites (7)

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

RECRUITING

Stockton Hematology Oncology Medical Group

Stockton, California, 95204, United States

RECRUITING

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

RECRUITING

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146, United States

RECRUITING

Oncology Consultants

Houston, Texas, 77030, United States

RECRUITING

Northwest Medical Specialities

Puyallup, Washington, 98373, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

biopsy specimen, whole blood, saliva, buccal swab

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma; Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms, Connective and Soft Tissue

Central Study Contacts

Rheanna Carter, MBA

CONTACT

650-773-0771; rheanna.carter@bostongene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 22, 2024
• Study Start: April 8, 2024
• Primary Completion: January 8, 2026
• Study Completion (Estimated): January 8, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)