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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma; Cancer; Adult Solid Tumor; Multiple Myeloma

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.

• Study Type: Observational
• Enrollment (Actual): 58213

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with histologically-documented solid tumors (including lymphoma or multiple myeloma), that have surplus clinical FFPE tumor tissue (e.g. biopsy, fine needle aspiration, fluid cytology, surgical resection) will be eligible for the Strata trial.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Discontinuation (TTD)	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	3 years
Time to Next Treatment (TTNT)	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	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biomarker profiles indicative of potential clinical benefit and affiliate trial enrollment	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.	3 years
Correlation between real world endpoints and overall survival endpoint	To assess the correlation between real world endpoints and overall survival endpoint	3 years

Collaborators and Investigators

• Sponsor: Strata Oncology
• Investigators: Study Director: Scott Tomlins, MD, Strata Oncology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 27, 2024
• Study Completion (Actual): June 27, 2024

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma
• Other Study ID Numbers: STR-001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No