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

February 23, 2023 updated by: Strata Oncology

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

Recruiting

Conditions

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 (Anticipated)

500000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Active, not recruiting
        • University of Alabama, Birmingham
    • California
      • Pasadena, California, United States, 91101
        • Completed
        • Kaiser Permanente - Southern California
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente - Northern California
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
    • Colorado
      • Broomfield, Colorado, United States, 80021
        • Recruiting
        • SCL Health
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
      • Denver, Colorado, United States, 80218
        • Completed
        • Kaiser Permanente Colorado
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Care Health System
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
    • Illinois
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • SwedishAmerican
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Recruiting
        • CHRISTUS Health
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Completed
        • Kaiser Permanente - Mid-Atlantic
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Active, not recruiting
        • Minnesota Oncology - Burnsville
      • Coon Rapids, Minnesota, United States, 55433
        • Active, not recruiting
        • Minnesota Oncology - Coon Rapids
      • Edina, Minnesota, United States, 55435
        • Active, not recruiting
        • Fairview Southdale Hospital
      • Maplewood, Minnesota, United States, 55109
        • Active, not recruiting
        • Minnesota Oncology - Maplewood Cancer Center
      • Maplewood, Minnesota, United States, 55109
        • Active, not recruiting
        • St. John's Hospital
      • Minneapolis, Minnesota, United States, 55101
        • Active, not recruiting
        • Metro-Minnesota Community Oncology Research Consortium
      • Minneapolis, Minnesota, United States, 55101
        • Active, not recruiting
        • Regions Hospital
      • Minneapolis, Minnesota, United States, 55404
        • Active, not recruiting
        • Minnesota Oncology - Minneapolis
      • Robbinsdale, Minnesota, United States, 55422
        • Active, not recruiting
        • North Memorial Health Care
      • Saint Louis Park, Minnesota, United States, 55416
        • Active, not recruiting
        • Park Nicollet Health Services
      • Saint Louis Park, Minnesota, United States, 55435
        • Active, not recruiting
        • Minnesota Oncology - Edina
      • Woodbury, Minnesota, United States, 55125
        • Active, not recruiting
        • Minnesota Oncology - Woodbury Clinic
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Completed
        • North Mississippi Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Completed
        • University of North Carolina, Chapel Hill
      • High Point, North Carolina, United States, 27262
        • Recruiting
        • Hayworth Cancer Center
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
      • Raleigh, North Carolina, United States, 27607
        • Completed
        • UNC Rex Healthcare
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Health Network
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
    • Oregon
      • Portland, Oregon, United States, 97227
        • Completed
        • Kaiser Permanente Northwest
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Health Network
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Completed
        • Prisma Health Cancer Institute
      • Greenville, South Carolina, United States, 29607
        • Active, not recruiting
        • Bon Secours St. Francis
    • Texas
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • UTHealth - Memorial Hemann Cancer Institute
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Active, not recruiting
        • Bon Secours Midlothian
    • Washington
      • Tacoma, Washington, United States, 98405
        • Completed
        • MultiCare
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Active, not recruiting
        • Gundersen Health System
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000
      • Marshfield, Wisconsin, United States, 54449
        • Active, not recruiting
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53226
        • Completed
        • Aurora Research Institute
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Care
        • Contact:
          • Strata Oncology
          • Phone Number: 734-527-1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with histologically-documented solid tumors (including lymphoma or multiple myeloma), and 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.
  • Must have an adequate formalin-fixed paraffin-embedded tumor specimen for genomic sequencing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Genetic Alteration Frequency
Time Frame: 3 years
To evaluate the proportion of subjects across solid tumors and lymphomas having genetic alterations targeted by approved or investigational therapies.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Treatment Selection
Time Frame: 3 years
To evaluate the proportion of advanced cancer subjects whose targeted genetic sequencing affected treatment selection and/or clinical trial enrollment.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Strata Oncology

Investigators

  • Study Director: Kat Kwiatkowski, MPH, Strata Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

April 1, 2026

Study Completion (Anticipated)

April 1, 2026

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)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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