Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment
NCT ID: NCT05455606
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1284 participants
INTERVENTIONAL
2022-10-14
2027-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Arm 1 (usual care)
Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.
Best Practice
Receive usual care
Chart Abstraction
Ancillary studies
Genomic Profile
Patients undergo genomic testing
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm 2 (EGTB)
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.
Chart Abstraction
Ancillary studies
Educational Intervention
Physicians access genomic testing education materials
Genomic Profile
Patients undergo genomic testing
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Tumor Board Review
Patients undergo genomic tumor board review
Interventions
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Best Practice
Receive usual care
Chart Abstraction
Ancillary studies
Educational Intervention
Physicians access genomic testing education materials
Genomic Profile
Patients undergo genomic testing
Interview
Ancillary studies
Questionnaire Administration
Ancillary studies
Tumor Board Review
Patients undergo genomic tumor board review
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 and patient participants to the study
* Recruitment Centers must be part of an NCORP or MU-NCORP site with Cancer Care Delivery Research (CCDR) funding as this study is supported by CCDR funding. Each clinic included in the Recruitment Center must be associated with Cancer Therapy Evaluation Program (CTEP) site identification (ID).
* Recruitment Centers must send large panel next generation sequencing genomic tests on 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 study and register within three months of study activation.
* Recruitment Centers must be willing to register a total of 66 patients (over 2 years) to the study.
* Centers must be able to send at least one member of the study team to attend the Recruitment Center's cases presented to the S2108CD Genomic Tumor Board, should the Recruitment Center be randomized to the intervention arm.
* Recruitment Centers must be willing and able to document the number of unique patients on which GTT is ordered at the Recruitment Center and submit this monthly to the S2108CD Study Team.
* PHYSICIAN PARTICIPANT INCLUSION
* Physician participant must be a registering investigator of the Recruitment Center that is participating in the study. If the physician is a registering investigator at more than one Recruitment Center, he/she must choose one Recruitment Center to identify with and enroll patients from.
* Physician participants must be board-eligible or board-certified in Medical Oncology, Gynecologic Oncology, or Neurology with certification or eligible for certification in Neuro-oncology.
* Physician participants must be willing to offer participation in the study to all eligible patients under their care for the duration of the study. A single physician may enroll multiple patients on the study.
* Physician participants must be willing to complete all study questionnaires and, as part of the implementation objective, participate in interviews if invited.
* Physician participants must complete all baseline questionnaires prior to registration.
* Physician participants at a Recruitment Center randomized to the intervention arm must 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 current diagnosis. The treating physician anticipates that the patient will start a new anti-cancer treatment (either first or subsequent lines) within 6 months after registration.
* Patient participants are allowed to be co-enrolled on other clinical trials including 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 prior to registration with results pending. The genomic testing may be a commercially available panel (such as FoundationOne, Caris, Tempus, etc.) or a non-commercial tumor 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 biopsy panels, including hotspot, whole gene, deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) (including expression data) panels. Fluorescence-in-situ hybridization (FISH) and immunohistochemistry test results assessing cancer-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 panel that includes NGS or expression profiling. These tests can come from any commercial or academic laboratory within the United States (US) and they should be ordered with the intent to influence genome-informed treatment decision. Oncotype DX and other panels used for making treatment decisions based on a prognostic read-out (e.g. liquid biopsy minimal residual disease \[MRD\]) are not permitted.
* 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 consent in accordance with institutional and federal guidelines. For patient participants with impaired decision-making capabilities, legally authorized representative may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations. Documentation of informed consent via remote consent is permissible.
Exclusion Criteria
* 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 an interdisciplinary team of clinicians and scientists that reviews genomic testing results and provides guidance on treatment options based primarily on genomic data to the treating physician. The existence of a general multidisciplinary tumor board that addresses all aspects of patient care and treatment is not considered an exclusion criterion. A general multidisciplinary tumor board is defined as an interdisciplinary team of clinicians that primarily discusses all aspects of cancer care, including diagnostic aspects (pathology and radiology), therapeutic options (surgical, radiation and medical) as well as palliative and psychosocial support options.
* PATIENT PARTICIPANT EXCLUSION
* Patient participants must not be going on hospice care at the time of registration.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Jens Rueter
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
HaysMed University of Kansas Health System
Hays, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Olathe Health Cancer Center
Olathe, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
Saint Joseph Hospital East
Lexington, Kentucky, United States
Saint Joseph London
London, Kentucky, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
Parkland Health Center - Farmington
Farmington, Missouri, United States
Truman Medical Centers
Kansas City, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union
Union, South Carolina, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, United States
Doctors Cancer Center
ManatÃ, , Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, , Puerto Rico
Countries
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Other Identifiers
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NCI-2022-04626
Identifier Type: REGISTRY
Identifier Source: secondary_id
S2108CD
Identifier Type: OTHER
Identifier Source: secondary_id
SWOG-S2108CD
Identifier Type: OTHER
Identifier Source: secondary_id
S2108CD
Identifier Type: OTHER
Identifier Source: secondary_id
S2108CD
Identifier Type: -
Identifier Source: org_study_id
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