Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment

Last updated: April 1, 2025
Sponsor: SWOG Cancer Research Network
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

Interview

Questionnaire Administration

Tumor Board Review

Clinical Study ID

NCT05455606
S2108CD
S2108CD
UG1CA189974
SWOG-S2108CD
NCI-2022-04626
  • Ages > 18
  • All Genders

Study Summary

This clinical trial studies how well an educationally enhanced genomic tumor board (EGTB) intervention works to increase the number of patients with solid tumors that have come back (recurrent), do not respond to treatment (refractory), have spread to other parts of the body (metastatic), or are newly diagnosed and spread to other parts of the body (advanced) who receive genome-informed treatment. Genome-informed treatment refers to treatment based on the information found in genomic tumor test results. This study compares the usual approach to reviewing genomic tumor test results with the approach of having a genomic tumor board (GTB) review the test results. A GTB is team of doctors and scientists that have experience in understanding genomic changes and review genomic tumor test results. The tumor board helps to suggest whether there are other cancer treatment options based on patient genetic test results. The usual approach is to review genomic tumor test results without the GTB being involved. This study may help researchers learn if using a GTB enhances the treatment decision making process within 6 months of joining the study. This study may also help researchers learn if using the GTB increases doctors' understanding of genomic tumor test results and increases doctors' comfort level with genomic tumor tests.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • RECRUITMENT CENTERS INCLUSION

  • A Recruitment Center is defined as an outpatient clinic, or group of clinics,belonging to the same National Cancer Institute Community Oncology Research Program (NCORP) or minority/underserved (MU)-NCORP, who will be contributing physicians andpatient participants to the study

  • Recruitment Centers must be part of an NCORP or MU-NCORP site with Cancer CareDelivery Research (CCDR) funding as this study is supported by CCDR funding. Eachclinic included in the Recruitment Center must be associated with Cancer TherapyEvaluation Program (CTEP) site identification (ID).

  • Recruitment Centers must send large panel next generation sequencing genomic testson at least 10 unique patients per month.

  • Recruitment Centers must have at least 4 practicing oncologists (including medical,gynecologic, or neuro-oncologists) at the site willing to participate in the studyand register within three months of study activation.

  • Recruitment Centers must be willing to register a total of 66 patients (over 2years) to the study.

  • Centers must be able to send at least one member of the study team to attend theRecruitment Center's cases presented to the S2108CD Genomic Tumor Board, should theRecruitment Center be randomized to the intervention arm.

  • Recruitment Centers must be willing and able to document the number of uniquepatients on which GTT is ordered at the Recruitment Center and submit this monthlyto the S2108CD Study Team.

  • PHYSICIAN PARTICIPANT INCLUSION

  • Physician participant must be a registering investigator of the Recruitment Centerthat is participating in the study. If the physician is a registering investigatorat more than one Recruitment Center, he/she must choose one Recruitment Center toidentify with and enroll patients from.

  • Physician participants must be board-eligible or board-certified in MedicalOncology, Gynecologic Oncology, or Neurology with certification or eligible forcertification in Neuro-oncology.

  • Physician participants must be willing to offer participation in the study to alleligible patients under their care for the duration of the study. A single physicianmay enroll multiple patients on the study.

  • Physician participants must be willing to complete all study questionnaires and, aspart of the implementation objective, participate in interviews if invited.

  • Physician participants must complete all baseline questionnaires prior toregistration.

  • Physician participants at a Recruitment Center randomized to the intervention armmust be willing to participate in the educationally enhanced GTB (EGTB).

  • PATIENT PARTICIPANT INCLUSION

  • Patient participants must have either recurrent, relapsed, refractory, metastatic,or newly diagnosed advanced stage III or stage IV solid tumor malignancy.

  • Patient participants must be under the care of a physician enrolled on the study.

  • Patient participants may have started anti-cancer treatment for the currentdiagnosis. The treating physician anticipates that the patient will start a newanti-cancer treatment (either first or subsequent lines) within 6 months afterregistration.

  • Patient participants are allowed to be co-enrolled on other clinical trialsincluding non-treatment studies and studies that include investigational drugs.Patients may be enrolled on genome-informed therapeutic trials, such as LungMAP,MATCH, TAPUR, etc.

  • Patient participants' genomic tumor test must have been ordered within 7 days priorto registration with results pending. The genomic testing may be a commerciallyavailable panel (such as FoundationOne, Caris, Tempus, etc.) or a non-commercialtumor panel performed at an academic medical center.

  • NOTE: Qualifying GTTs are defined as Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) tissue or liquid biopsypanels, including hotspot, whole gene, deoxyribonucleic acid (DNA) andribonucleic acid (RNA) (including expression data) panels. Fluorescence-in-situhybridization (FISH) and immunohistochemistry test results assessingcancer-relevant proteins (e.g. Her2/neu, ALK, MET) and immune parameters (e.g.PD-L1 tests) are also permissible if performed in the context of a larger panelthat includes NGS or expression profiling. These tests can come from anycommercial or academic laboratory within the United States (US) and they shouldbe ordered with the intent to influence genome-informed treatment decision.Oncotype DX and other panels used for making treatment decisions based on aprognostic read-out (e.g. liquid biopsy minimal residual disease [MRD]) are notpermitted.

  • Patient participants must be at least 18 years of age.

  • Patient participants must have a Zubrod performance status of 0-2.

  • Participants (patients and physicians) must sign and give written informed consentin accordance with institutional and federal guidelines. For patient participantswith impaired decision-making capabilities, legally authorized representative maysign and give informed consent on behalf of study participants in accordance withapplicable federal, local, and Central Institutional Review Board (CIRB)regulations. Documentation of informed consent via remote consent is permissible.

Exclusion

Exclusion Criteria:

  • RECRUITMENT CENTERS EXCLUSION

  • Recruitment Centers must not have or utilize an existing Genomic Tumor Board (GTB).For the purposes of this study, a Genomic Tumor Board is defined as aninterdisciplinary team of clinicians and scientists that reviews genomic testingresults and provides guidance on treatment options based primarily on genomic datato the treating physician. The existence of a general multidisciplinary tumor boardthat addresses all aspects of patient care and treatment is not considered anexclusion criterion. A general multidisciplinary tumor board is defined as aninterdisciplinary team of clinicians that primarily discusses all aspects of cancercare, including diagnostic aspects (pathology and radiology), therapeutic options (surgical, radiation and medical) as well as palliative and psychosocial supportoptions.

  • PATIENT PARTICIPANT EXCLUSION

  • Patient participants must not be going on hospice care at the time of registration.

Study Design

Total Participants: 1284
Treatment Group(s): 7
Primary Treatment: Interview
Phase:
Study Start date:
October 14, 2022
Estimated Completion Date:
December 15, 2025

Study Description

PRIMARY OBJECTIVE:

I. To determine whether an EGTB intervention compared to usual practice increases the proportion of patients who receive evidence-based genome-informed therapy within 6 months after registration to the study.

SECONDARY OBJECTIVES:

I. To compare physician genomic confidence and physician experience with genomic tumor testing (GTT) between arms at baseline and end of study.

II. To compare clinical outcomes between arms by assessing patient survival and time to treatment discontinuation.

III. To compare physician assessment of evidence-based genome-informed therapy to the central study team determination of evidence-based genome-informed therapy, both overall and separately by arm.

IMPLEMENTATION OBJECTIVES:

I. To assess the utilization of GTT and implementation of the EGTB intervention into clinic workflow in order to better understand barriers and facilitators at Recruitment Centers assigned to the active intervention arm using a mixed-methods approach.

II. To assess the evolution of GTT utilization within clinic workflows at recruitment centers assigned to the usual practice (control) arm using a mixed-methods approach.

OUTLINE: Study clinics are randomized to 1 of 2 arms. Participants receive interventions based on this randomization.

ARM 1: Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

ARM 2: Patients and physicians receive the EGTB intervention. This is comprised of 2 components: the structured GTB and the supporting education. Physicians submit cases for discussion to the GTB within 2 weeks of GTT results. The GTB sessions are held weekly and conducted virtually over a video-conferencing platform. Each case presentation is 10 to 15 minutes long, and 4 to 6 cases are discussed during each 60 minute GTB session. GTT results and clinical data are presented and expert interpretation of genomic test results is provided to help prioritize potential treatment options and provide a framework for interpretation. Supporting education materials are also available online to participants to support GTT decision making.

Physicians are followed until the end of the study or through 6 months after their last patient was registered to the study, whichever is later. Patients are followed for 24 months after registration or until a criterion for removal from protocol participation is met, whichever comes first.

Connect with a study center

  • Doctors Cancer Center

    Manati, 00674
    Puerto Rico

    Site Not Available

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Hawaii Cancer Care - Westridge

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Pali Momi Medical Center

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Straub Clinic and Hospital

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho 83854
    United States

    Site Not Available

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois 61704
    United States

    Site Not Available

  • Illinois CancerCare-Canton

    Canton, Illinois 61520
    United States

    Site Not Available

  • Carle at The Riverfront

    Danville, Illinois 61832
    United States

    Site Not Available

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois 61938
    United States

    Site Not Available

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Illinois CancerCare-Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa 50309
    United States

    Site Not Available

  • HaysMed University of Kansas Health System

    Hays, Kansas 67601
    United States

    Site Not Available

  • Lawrence Memorial Hospital

    Lawrence, Kansas 66044
    United States

    Site Not Available

  • Olathe Health Cancer Center

    Olathe, Kansas 66061
    United States

    Site Not Available

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Salina Regional Health Center

    Salina, Kansas 67401
    United States

    Site Not Available

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Saint Joseph Hospital East

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Saint Joseph London

    London, Kentucky 40741
    United States

    Site Not Available

  • The Jackson Laboratory

    Bar Harbor, Maine 04609
    United States

    Site Not Available

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Saint Joseph Mercy Brighton

    Brighton, Michigan 48114
    United States

    Site Not Available

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan 48118
    United States

    Site Not Available

  • Ascension Saint John Hospital

    Detroit, Michigan 48236
    United States

    Site Not Available

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan 48154
    United States

    Site Not Available

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan 48341
    United States

    Site Not Available

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota 56401
    United States

    Site Not Available

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • Essentia Health Cancer Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Unity Hospital

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • New Ulm Medical Center

    New Ulm, Minnesota 56073
    United States

    Site Not Available

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • Lakeview Hospital

    Stillwater, Minnesota 55082
    United States

    Site Not Available

  • Ridgeview Medical Center

    Waconia, Minnesota 55387
    United States

    Site Not Available

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Fairview Lakes Medical Center

    Wyoming, Minnesota 55092
    United States

    Site Not Available

  • Parkland Health Center - Farmington

    Farmington, Missouri 63640
    United States

    Site Not Available

  • Truman Medical Centers

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • University of Kansas Cancer Center - North

    Kansas City, Missouri 64154
    United States

    Site Not Available

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri 64064
    United States

    Site Not Available

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri 64116
    United States

    Site Not Available

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri 65401
    United States

    Site Not Available

  • Missouri Baptist Medical Center

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri 63670
    United States

    Site Not Available

  • CoxHealth South Hospital

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri 63080
    United States

    Site Not Available

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri 63127
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina 28374
    United States

    Site Not Available

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina 29910
    United States

    Site Not Available

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina 29341
    United States

    Site Not Available

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Spartanburg Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • MGC Hematology Oncology-Union

    Union, South Carolina 29379
    United States

    Site Not Available

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin 53045
    United States

    Site Not Available

  • Ascension Saint Francis - Reiman Cancer Center

    Franklin, Wisconsin 53132
    United States

    Site Not Available

  • Ascension Columbia Saint Mary's Hospital Ozaukee

    Mequon, Wisconsin 53097
    United States

    Site Not Available

  • Ascension Medical Group Southeast Wisconsin - Mayfair Road

    Wauwatosa, Wisconsin 53226
    United States

    Site Not Available

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