Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-04-08
2028-01-08
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Breast cancer
Patients with locally recurrent, unresectable or metastatic breast cancer
No interventions assigned to this group
NSCLC
Patients with unresectable stage III or metastatic non-small cell lung cancer
No interventions assigned to this group
Melanoma
Patients with unresectable or metastatic melanoma
No interventions assigned to this group
Sarcoma
Patients with locally advanced or metastatic sarcoma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Exigent
UNKNOWN
BostonGene
INDUSTRY
Responsible Party
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Locations
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Highlands Oncology Group
Rogers, Arkansas, United States
Stockton Hematology Oncology Medical Group
Stockton, California, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, United States
Oncology Consultants
Houston, Texas, United States
Northwest Medical Specialities
Puyallup, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BEGIN study
Identifier Type: -
Identifier Source: org_study_id
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