Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
- Conditions
- Adult Solid TumorCancerLymphomaMultiple Myeloma
- Registration Number
- NCT03061305
- Lead Sponsor
- Strata Oncology
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 58213
-
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.
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (40)
Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Prisma Health Cancer Institute
🇺🇸Greenville, South Carolina, United States
SCL Health
🇺🇸Broomfield, Colorado, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente - Southern California
🇺🇸Pasadena, California, United States
Kaiser Permanente - Northern California
🇺🇸Vallejo, California, United States
Kaiser Permanente Colorado
🇺🇸Denver, Colorado, United States
Christiana Care Health System
🇺🇸Newark, Delaware, United States
SwedishAmerican
🇺🇸Rockford, Illinois, United States
Baptist Health
🇺🇸Lexington, Kentucky, United States
Christus Health
🇺🇸Lake Charles, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Kaiser Permanente - Mid-Atlantic
🇺🇸Rockville, Maryland, United States
Minnesota Oncology - Burnsville
🇺🇸Burnsville, Minnesota, United States
Minnesota Oncology - Coon Rapids
🇺🇸Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Minnesota Oncology - Maplewood Cancer Center
🇺🇸Maplewood, Minnesota, United States
St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Metro-Minnesota Community Oncology Research Consortium
🇺🇸Minneapolis, Minnesota, United States
Regions Hospital
🇺🇸Minneapolis, Minnesota, United States
Minnesota Oncology - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
North Memorial Health Care
🇺🇸Robbinsdale, Minnesota, United States
Park Nicollet Health Services
🇺🇸Saint Louis Park, Minnesota, United States
Minnesota Oncology - Edina
🇺🇸Saint Louis Park, Minnesota, United States
Minnesota Oncology - Woodbury Clinic
🇺🇸Woodbury, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Hayworth Cancer Center
🇺🇸High Point, North Carolina, United States
UNC REX Healthcare
🇺🇸Raleigh, North Carolina, United States
Kettering Health Network
🇺🇸Kettering, Ohio, United States
Bon Secours St. Francis
🇺🇸Greenville, South Carolina, United States
UTHealth - Memorial Hemann Cancer Institute
🇺🇸Houston, Texas, United States
Bon Secours Midlothian
🇺🇸Midlothian, Virginia, United States
MultiCare
🇺🇸Tacoma, Washington, United States
Gundersen Health System
🇺🇸La Crosse, Wisconsin, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Aurora Research Institute
🇺🇸Milwaukee, Wisconsin, United States
ProHealth Care
🇺🇸Waukesha, Wisconsin, United States