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
Enrollment
40
Locations
12500
Patients Per Site

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 DiseaseIntervention/TreatmentPhase

    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

    SiteCityStateCountryPostal Code
    1University of Alabama, BirminghamBirminghamAlabamaUnited States35294
    2Kaiser Permanente - Southern CaliforniaPasadenaCaliforniaUnited States91101
    3Kaiser Permanente - Northern CaliforniaVallejoCaliforniaUnited States94589
    4SCL HealthBroomfieldColoradoUnited States80021
    5Kaiser Permanente ColoradoDenverColoradoUnited States80218
    6Christiana Care Health SystemNewarkDelawareUnited States19713
    7SwedishAmericanRockfordIllinoisUnited States61114
    8Baptist HealthLexingtonKentuckyUnited States40503
    9Christus HealthLake CharlesLouisianaUnited States70605
    10Ochsner Clinic FoundationNew OrleansLouisianaUnited States70121
    11Kaiser Permanente - Mid-AtlanticRockvilleMarylandUnited States20852
    12Minnesota Oncology - BurnsvilleBurnsvilleMinnesotaUnited States55337
    13Minnesota Oncology - Coon RapidsCoon RapidsMinnesotaUnited States55433
    14Fairview Southdale HospitalEdinaMinnesotaUnited States55435
    15Minnesota Oncology - Maplewood Cancer CenterMaplewoodMinnesotaUnited States55109
    16St. John's HospitalMaplewoodMinnesotaUnited States55109
    17Metro-Minnesota Community Oncology Research ConsortiumMinneapolisMinnesotaUnited States55101
    18Regions HospitalMinneapolisMinnesotaUnited States55101
    19Minnesota Oncology - MinneapolisMinneapolisMinnesotaUnited States55404
    20North Memorial Health CareRobbinsdaleMinnesotaUnited States55422
    21Park Nicollet Health ServicesSaint Louis ParkMinnesotaUnited States55416
    22Minnesota Oncology - EdinaSaint Louis ParkMinnesotaUnited States55435
    23Minnesota Oncology - Woodbury ClinicWoodburyMinnesotaUnited States55125
    24North Mississippi Medical CenterTupeloMississippiUnited States38801
    25University of North Carolina, Chapel HillChapel HillNorth CarolinaUnited States27514
    26Hayworth Cancer CenterHigh PointNorth CarolinaUnited States27262
    27UNC REX HealthcareRaleighNorth CarolinaUnited States27607
    28Kettering Health NetworkKetteringOhioUnited States45429
    29Kaiser Permanente NorthwestPortlandOregonUnited States97227
    30Lehigh Valley Health NetworkAllentownPennsylvaniaUnited States18103
    31Prisma Health Cancer InstituteGreenvilleSouth CarolinaUnited States29605
    32Bon Secours St. FrancisGreenvilleSouth CarolinaUnited States29607
    33UTHealth - Memorial Hemann Cancer InstituteHoustonTexasUnited States77030
    34Bon Secours MidlothianMidlothianVirginiaUnited States23114
    35MultiCareTacomaWashingtonUnited States98405
    36Gundersen Health SystemLa CrosseWisconsinUnited States54601
    37University of WisconsinMadisonWisconsinUnited States53792
    38Marshfield ClinicMarshfieldWisconsinUnited States54449
    39Aurora Research InstituteMilwaukeeWisconsinUnited States53226
    40ProHealth CareWaukeshaWisconsinUnited States53188

    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