Multiple Myeloma Clinical Trial

Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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:

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.
Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

500000

Study ID:

NCT03061305

Recruitment Status:

Recruiting

Sponsor:

Strata Oncology

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There are 37 Locations for this study

See Locations Near You

University of Alabama, Birmingham
Birmingham Alabama, 35294, United States
Kaiser Permanente - Southern California
Pasadena California, 91101, United States
Kaiser Permanente - Northern California
Vallejo California, 94589, United States More Info
Strata Oncology
Contact
734-527-1000
SCL Health
Broomfield Colorado, 80021, United States More Info
Strata Oncology
Contact
734-527-1000
Kaiser Permanente Colorado
Denver Colorado, 80218, United States
Christiana Care Health System
Newark Delaware, 19713, United States More Info
Strata Oncology
Contact
734-527-1000
SwedishAmerican
Rockford Illinois, 61114, United States More Info
Strata Oncology
Contact
734-527-1000
Baptist Health
Lexington Kentucky, 40503, United States More Info
Strata Oncology
Contact
734-527-1000
Christus Health
Lake Charles Louisiana, 70605, United States More Info
Strata Oncology
Contact
734-527-1000
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States More Info
Strata Oncology
Contact
734-527-1000
Kaiser Permanente - Mid-Atlantic
Rockville Maryland, 20852, United States
Minnesota Oncology - Burnsville
Burnsville Minnesota, 55337, United States
Minnesota Oncology - Coon Rapids
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Minnesota Oncology - Maplewood Cancer Center
Maplewood Minnesota, 55109, United States
St. John's Hospital
Maplewood Minnesota, 55109, United States
Metro-Minnesota Community Oncology Research Consortium
Minneapolis Minnesota, 55101, United States
Regions Hospital
Minneapolis Minnesota, 55101, United States
Minnesota Oncology - Minneapolis
Minneapolis Minnesota, 55404, United States
North Memorial Health Care
Robbinsdale Minnesota, 55422, United States
Park Nicollet Health Services
Saint Louis Park Minnesota, 55416, United States
Minnesota Oncology - Edina
Saint Louis Park Minnesota, 55435, United States
Minnesota Oncology - Woodbury Clinic
Woodbury Minnesota, 55125, United States
North Mississippi Medical Center
Tupelo Mississippi, 38801, United States
University of North Carolina, Chapel Hill
Chapel Hill North Carolina, 27514, United States
Hayworth Cancer Center
High Point North Carolina, 27262, United States More Info
Strata Oncology
Contact
734-527-1000
UNC REX Healthcare
Raleigh North Carolina, 27607, United States
Kettering Health Network
Kettering Ohio, 45429, United States More Info
Strata Oncology
Contact
734-527-1000
Kaiser Permanente Northwest
Portland Oregon, 97227, United States
Lehigh Valley Health Network
Allentown Pennsylvania, 18103, United States More Info
Strata Oncology
Contact
734-527-1000
Prisma Health Cancer Institute
Greenville South Carolina, 29605, United States
Bon Secours St. Francis
Greenville South Carolina, 29607, United States
UTHealth - Memorial Hemann Cancer Institute
Houston Texas, 77030, United States
Bon Secours Midlothian
Midlothian Virginia, 23114, United States
MultiCare
Tacoma Washington, 98405, United States
Gundersen Health System
La Crosse Wisconsin, 54601, United States
University of Wisconsin
Madison Wisconsin, 53792, United States More Info
Strata Oncology
Contact
734-527-1000
Marshfield Clinic
Marshfield Wisconsin, 54449, United States
Aurora Research Institute
Milwaukee Wisconsin, 53226, United States
ProHealth Care
Waukesha Wisconsin, 53188, United States More Info
Strata Oncology
Contact
734-527-1000

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

500000

Study ID:

NCT03061305

Recruitment Status:

Recruiting

Sponsor:


Strata Oncology

How clear is this clinincal trial information?

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