Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03061305|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : September 29, 2021
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.
|Condition or disease|
|Cancer Adult Solid Tumor Lymphoma Multiple Myeloma|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||April 2026|
- Genetic Alteration Frequency [ Time Frame: 3 years ]To evaluate the proportion of subjects across solid tumors and lymphomas having genetic alterations targeted by approved or investigational therapies.
- Assessment of Treatment Selection [ Time Frame: 3 years ]To evaluate the proportion of advanced cancer subjects whose targeted genetic sequencing affected treatment selection and/or clinical trial enrollment.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061305
|Contact: Kat Kwiatkowski, MPHfirstname.lastname@example.org|
|Study Director:||Kat Kwiatkowski, MPH||Strata Oncology|