Recruiting

BostonGene & Exigent

Sponsor:

BostonGene

Code:

NCT06272864

Conditions

Breast Cancer

Non-small Cell Lung Cancer

Melanoma

Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06272864

Start date

Apr 8, 2024

Status verified date

Feb, 2025

Completion date

Jan 8, 2028

Anticipated

Primary completion date

Jan 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Frequency of actionable findings [ Time Frame: 2 years ]
  • Test turn-around time [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Rheanna Carter, MBA

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

Locations

Highlands Oncology Group

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Adam Torres

ATorres@hogonc.com

Principal Investigator:

Eric Schaefer, MD

Stockton Hematology Oncology Medical Group

Recruiting

Stockton, California, United States, 95204

Contacts

Lizbeth Ortiz

lortiz@shomg.net

Principal Investigator:

Dheeraj Kodali, MD

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Phil Huston

phil.hutson@fwmoh.com

Principal Investigator:

Sunil Babu, MD

New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87109

Contacts

Valerie Tucker

valeriet@nmohc.com

Principal Investigator:

Katherine Sanchez, MD

Oklahoma Cancer Specialists and Research Institute

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Ruth Dunn

ruth.dunn@ocsri.org

Principal Investigator:

Paul Zito, MD

Oncology Consultants

Recruiting

Houston, Texas, United States, 77030

Contacts

Laura Guerra

lguerra@OncologyConsultants.com

Principal Investigator:

Julio Peguero, MD

Northwest Medical Specialities

Recruiting

Puyallup, Washington, United States, 98373

Contacts

Malee Chhan

mchhan@nwmsonline.com

Principal Investigator:

Sibel Blau, MD

More Information

Sponsor

BostonGene

Last update posted

Feb 17, 2025

Last verified

Feb, 2025

Keywords

  • Comprehensive Molecular Testing
  • BostonGene Tumor Portrait Test
  • Molecularly Matched Therapy
  • DNA and RNA Targets

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BostonGene on 2025-02-17.