An observational study in Cancer, Adult Solid Tumor and Lymphoma, sponsored by Strata Oncology. Terminated at 40 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by Strata Oncology · Observational
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.
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 58,213 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Strata Oncology is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult subjects with histologically-documented solid tumors (including lymphoma or multiple myeloma), that have surplus clinical FFPE tumor tissue (e.g. biopsy, fine needle aspiration, fluid cytology, surgical resection) will be eligible for the Strata trial.
Inclusion Criteria:
Specific criteria for individual tumor types are as follows:
Time to Treatment Discontinuation (TTD)
To evaluate TTD for participants who received an anticancer biomarker-guided therapy and, when available, as compared to prior TTD from prior anti-cancer therapy
Time frame: 3 years
Time to Next Treatment (TTNT)
To evaluate TTNT for participants who received and anticancer biomarker guided therapy and, when available, as compared to prior TTNT from prior anti-cancer therapy
Time frame: 3 years
biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment
To evaluate the proportion of participants with actionable genomic profiles that indicate a potential clinical benefit from standard of care biomarker-guided therapies or a clinical trial, and the proportion of participants who enroll on a clinical trial.
Time frame: 3 years
Correlation between real world endpoints and overall survival endpoint
To assess the correlation between real world endpoints and overall survival endpoint
Time frame: 3 years
Plan to share: No
Ran from Nov 2016 to primary completion in Jun 2024, 91 months.
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Strata Oncology