Breast CancerBEGINNCT06272864
BostonGene and Exigent Genomic INsight Study
An observational study of Breast Cancer and Non-small Cell Lung Cancer, run by BostonGene at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Non-small Cell Lung Cancer, Melanoma
- How many people
- 400 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Apr 2024to 8 Jan 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced cancer patients
Who may be able to join
- 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
Who cannot join
- not meeting the inclusion criteria
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
New Mexico Cancer Center
Albuquerque, New Mexico, 87109
Valerie Tucker, valeriet@nmohc.com
Katherine Sanchez, MD
- Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Phil Huston, phil.hutson@fwmoh.com
Sunil Babu, MD
- Recruiting
Oncology Consultants
Houston, Texas, 77030
Laura Guerra, lguerra@OncologyConsultants.com
Julio Peguero, MD
- Recruiting
Northwest Medical Specialities
Puyallup, Washington, 98373
Malee Chhan, mchhan@nwmsonline.com
Sibel Blau, MD
- Recruiting
Highlands Oncology Group
Rogers, Arkansas, 72758
Adam Torres, ATorres@hogonc.com
Eric Schaefer, MD
- Recruiting
Stockton Hematology Oncology Medical Group
Stockton, California, 95204
Lizbeth Ortiz, lortiz@shomg.net
Dheeraj Kodali, MD
- Recruiting
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146
Ruth Dunn, ruth.dunn@ocsri.org
Paul Zito, MD
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 years
Secondary outcomes (2)
Frequency of patients who receive molecularly matched therapy
the frequency of patients who receive molecularly matched therapy within 6 months of undergoing genomic testing
Measured: 6 months
Frequency of patients who receive molecularly matched therapy
the frequency of patients who receive molecularly matched therapy within 12 months of undergoing genomic testing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start8 Apr 2024
- Primary completion8 Jan 2026 (estimated)
- Study completion8 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- BostonGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Exigent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272864
- Sponsor's protocol ID
- BEGIN study
- Acronym
- BEGIN
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BostonGene and Exigent Genomic INsight (BEGIN) Study: A Prospective Study of Comprehensive Molecular Testing in Advanced Cancer Patients in the Community Setting
- ClinicalTrials.gov ID
- NCT06272864
- Acronym / sponsor ID
- BEGIN / BEGIN study
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- BostonGeneIndustry (pharma, biotech, devices)
- Collaborators
- Exigent
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 8 Jan 2026 (estimated)
- Study completion
- 8 Jan 2028 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced cancer patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 secondary outcomes
Frequency of patients who receive molecularly matched therapy
Time frame: 6 months
Frequency of patients who receive molecularly matched therapy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Non-small Cell Lung Cancer, run by BostonGene at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rheanna Carter, MBA (650-773-0771, rheanna.carter@bostongene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of actionable findings (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.