Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors

Study Overview
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Brief Summary
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Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. The Strata Trial (STR-001-001) has been initiated by Strata Oncology to evaluate the clinical benefit of systematic comprehensive genomic profiling for participants with advanced cancer using real-world data and endpoints, while assessing the proportion of participants available for clinical trials and approved targeted therapies in advanced and/or aggressive cancers. The Strata Trial uses surplus, or leftover, tumor specimens for molecular profiling and does not require additional study-specific procedures.

Detailed Description
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Participants enrolled on the Strata Trial will submit surplus, clinical formalin-fixed paraffin-embedded (FFPE) tumor specimens for molecular profiling and a test report will be provided back to the investigator. For those participants identified as having molecular alterations associated with a Strata-affiliated therapeutic clinical trial and/or approved targeted therapy or trials, the Strata reports will provide additional relevant information. All molecular profiling will be performed in the Strata Oncology CAP-accredited and CLIA-certified laboratory (Ann Arbor, MI). The molecular profiling assays will include tumor-only comprehensive genomic profiling (CGP) by next generation sequencing (NGS) of DNA and RNA covering a range of actionable genomic alterations, such as mutations (e.g. those in EGFR and BRAF), copy number alterations (e.g. ERBB2 amplifications), gene expression, gene fusions (e.g. ALK fusions), tumor mutation burden (TMB) and microsatellite instability status, and may include additional integrative DNA and RNA tests over time. Participants may be followed for treatment changes and survival for three years from the time of enrollment and/or signed informed consent. Participants may also be eligible for the Strata Trial Sub-Study at applicable Strata Trial sites. This sub-study is a sample collection study to support the development and evaluation of biomarker assays for patients with solid tumors.

Official Title
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An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors

Conditions
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Cancer, Adult Solid Tumor, Lymphoma, Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be ≥ 18 years of age. Subjects must have histologically documented solid tumors (including lymphoma and multiple myeloma). Specific criteria for individual tumor types are as follows: Participants with gliomas are eligible at any stage of disease Participants with pancreatic carcinoma are eligible at any stage of disease Participants with rare tumors (i.e. cancer started in an unusual place in the body, it is unusual type and requires special treatment) are eligible at stages II-IV. Participants with other tumor types must have recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer. Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic Alteration Frequency | To evaluate the proportion of subjects across solid tumors and lymphomas having genetic alterations targeted by approved or investigational therapies. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Treatment Selection | To evaluate the proportion of advanced cancer subjects whose targeted genetic sequencing affected treatment selection and/or clinical trial enrollment. | 3 years |