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

NCT ID: NCT03061305

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 58213 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2024-06-27

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.

Conditions

Cancer; Adult Solid Tumor; Lymphoma; Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Strata Oncology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Tomlins, MD

Role: STUDY_DIRECTOR

Strata Oncology

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

Countries

United States

References

Tomlins SA, Hovelson DH, Suga JM, Anderson DM, Koh HA, Dees EC, McNulty B, Burkard ME, Guarino M, Khatri J, Safa MM, Matrana MR, Yang ES, Menter AR, Parsons BM, Slim JN, Thompson MA, Hwang L, Edenfield WJ, Nair S, Onitilo A, Siegel R, Miller A, Wassenaar T, Irvin WJ, Schulz W, Padmanabhan A, Harish V, Gonzalez A, Mansoor AH, Kellum A, Harms P, Drewery S, Falkner J, Fischer A, Hipp J, Kwiatkowski K, Lazo de la Vega L, Mitchell K, Reeder T, Siddiqui J, Vakil H, Johnson DB, Rhodes DR. Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples. JCO Precis Oncol. 2021 Aug 19;5:PO.20.00472. doi: 10.1200/PO.20.00472. eCollection 2021 Aug.

Reference Type: DERIVED

PMID: 34476329 (View on PubMed)

Other Identifiers

STR-001-001

Identifier Type: -

Identifier Source: org_study_id