Spots Global Cancer Trial Database for Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
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Trial Identification
Brief Title: Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
Official Title: An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
Study ID: NCT03061305
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Birmingham, Alabama, United States
Kaiser Permanente - Southern California, Pasadena, California, United States
Kaiser Permanente - Northern California, Vallejo, California, United States
SCL Health, Broomfield, Colorado, 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
Kaiser Permanente Northwest, Portland, Oregon, United States
Lehigh Valley Health Network, Allentown, Pennsylvania, United States
Prisma Health Cancer Institute, Greenville, South Carolina, 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
Contact Details
Name: Kat Kwiatkowski, MPH
Affiliation: Strata Oncology
Role: STUDY_DIRECTOR
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