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

Sponsor
Strata Oncology (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03061305
Collaborator
(none)
500,000
40
12500

Study Details

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Trial Assessing the Clinical Benefit of Molecular Profiling in Patients With Solid Tumors
    Actual Study Start Date :
    Nov 1, 2016
    Anticipated Primary Completion Date :
    Apr 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Genetic Alteration Frequency [3 years]

      To evaluate the proportion of subjects across solid tumors and lymphomas having genetic alterations targeted by approved or investigational therapies.

    Secondary Outcome Measures

    1. Assessment of Treatment Selection [3 years]

      To evaluate the proportion of advanced cancer subjects whose targeted genetic sequencing affected treatment selection and/or clinical trial enrollment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama, Birmingham Birmingham Alabama United States 35294
    2 Kaiser Permanente - Southern California Pasadena California United States 91101
    3 Kaiser Permanente - Northern California Vallejo California United States 94589
    4 SCL Health Broomfield Colorado United States 80021
    5 Kaiser Permanente Colorado Denver Colorado United States 80218
    6 Christiana Care Health System Newark Delaware United States 19713
    7 SwedishAmerican Rockford Illinois United States 61114
    8 Baptist Health Lexington Kentucky United States 40503
    9 Christus Health Lake Charles Louisiana United States 70605
    10 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    11 Kaiser Permanente - Mid-Atlantic Rockville Maryland United States 20852
    12 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    13 Minnesota Oncology - Coon Rapids Coon Rapids Minnesota United States 55433
    14 Fairview Southdale Hospital Edina Minnesota United States 55435
    15 Minnesota Oncology - Maplewood Cancer Center Maplewood Minnesota United States 55109
    16 St. John's Hospital Maplewood Minnesota United States 55109
    17 Metro-Minnesota Community Oncology Research Consortium Minneapolis Minnesota United States 55101
    18 Regions Hospital Minneapolis Minnesota United States 55101
    19 Minnesota Oncology - Minneapolis Minneapolis Minnesota United States 55404
    20 North Memorial Health Care Robbinsdale Minnesota United States 55422
    21 Park Nicollet Health Services Saint Louis Park Minnesota United States 55416
    22 Minnesota Oncology - Edina Saint Louis Park Minnesota United States 55435
    23 Minnesota Oncology - Woodbury Clinic Woodbury Minnesota United States 55125
    24 North Mississippi Medical Center Tupelo Mississippi United States 38801
    25 University of North Carolina, Chapel Hill Chapel Hill North Carolina United States 27514
    26 Hayworth Cancer Center High Point North Carolina United States 27262
    27 UNC REX Healthcare Raleigh North Carolina United States 27607
    28 Kettering Health Network Kettering Ohio United States 45429
    29 Kaiser Permanente Northwest Portland Oregon United States 97227
    30 Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    31 Prisma Health Cancer Institute Greenville South Carolina United States 29605
    32 Bon Secours St. Francis Greenville South Carolina United States 29607
    33 UTHealth - Memorial Hemann Cancer Institute Houston Texas United States 77030
    34 Bon Secours Midlothian Midlothian Virginia United States 23114
    35 MultiCare Tacoma Washington United States 98405
    36 Gundersen Health System La Crosse Wisconsin United States 54601
    37 University of Wisconsin Madison Wisconsin United States 53792
    38 Marshfield Clinic Marshfield Wisconsin United States 54449
    39 Aurora Research Institute Milwaukee Wisconsin United States 53226
    40 ProHealth Care Waukesha Wisconsin United States 53188

    Sponsors and Collaborators

    • Strata Oncology

    Investigators

    • Study Director: Kat Kwiatkowski, MPH, Strata Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Strata Oncology
    ClinicalTrials.gov Identifier:
    NCT03061305
    Other Study ID Numbers:
    • STR-001-001
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 29, 2021