Adult Solid Tumor, Cancer, Lymphoma, Multiple Myeloma
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Strata Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Participants with gliomas are eligible at any stage of disease 2. Participants with pancreatic carcinoma are eligible at any stage of disease 3. 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. 4. Participants with other tumor types must have recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Discontinuation (TTD) | 3 years | 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 to Next Treatment (TTNT) | 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment | 3 years | 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. |
| Correlation between real world endpoints and overall survival endpoint | 3 years | To assess the correlation between real world endpoints and overall survival endpoint |
Countries
United States
Outcome results
None listed