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

NCT05455606 | Active Not Recruiting DMC

• 4 other identifiers: S2108CDNCI-2022-04626SWOG-S2108CDUG1CA189974
• Study Type: interventional
• Target: 1,284
• Locations: 2 countries
• Sites: 72

Brief 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.

Conditions

Advanced Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Percent of patients who receive a treatment that targets a genomic variant for which there is sufficient data to support actionability

  Evidence-based genome-informed therapy is defined as the use of a treatment that targets a genomic variant for which there is sufficient data to support actionability. This is a patient-specific measure determined through blinded central review of patient data, following the schemas in the protocol. An independent panel of investigators blinded to the study arm assignment of the study participant will evaluate redacted data from each subject for determination of the primary endpoint. Data supporting the primary endpoint are obtained from the genomic tumor test results PDF, pathology report, primary tumor type, and the S2108CD Treatment Form as well as curated evidence plus evidence level (tier) designation from the Jackson Labs Clinical Knowledge Base.

  Within 6 months of study completion

Secondary Outcomes (6)

• Physician genomic confidence

  Baseline and month 27 after study activation

• Physician experience using genomic tumor testing (GTT) in practice

  Baseline and month 27 after study activation

• Overall survival

  From registration until death due to any cause, assessed up to 24 months

• Overall survival on new anticancer therapy

  From the time new anticancer therapy is initiated on study until deathdue to any cause, assessed up to 24 months

• Time to treatment discontinuation

  From registration until the last dose recorded or death, assessed up to 24 months

Study Arms (2)

Arm 1 (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Chart Abstraction; Procedure: Genomic Profile; Other: Interview; Other: Questionnaire Administration

Arm 2 (EGTB)

EXPERIMENTAL

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.

Other: Chart Abstraction; Other: Educational Intervention; Procedure: Genomic Profile; Other: Interview; Other: Questionnaire Administration; Other: Tumor Board Review

Interventions

Interview OTHER

Ancillary studies

Arm 1 (usual care); Arm 2 (EGTB)

Tumor Board Review OTHER

Patients undergo genomic tumor board review

Also known as: multidisciplinary opinion

Arm 2 (EGTB)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (usual care); Arm 2 (EGTB)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm 1 (usual care)

Chart Abstraction OTHER

Ancillary studies

Arm 1 (usual care); Arm 2 (EGTB)

Educational Intervention OTHER

Physicians access genomic testing education materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm 2 (EGTB)

Genomic Profile PROCEDURE

Patients undergo genomic testing

Also known as: genetic profile, Genome Profile, Genomic Profiling, Genomic Test, Genomic Testing

Arm 1 (usual care); Arm 2 (EGTB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• SWOG Cancer Research Network: lead

Study Sites (72)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

Location

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

Savannah, Georgia, 31405, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

HaysMed University of Kansas Health System

Hays, Kansas, 67601, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Olathe Health Cancer Center

Olathe, Kansas, 66061, United States

Location

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

Location

Saint Joseph Hospital East

Lexington, Kentucky, 40509, United States

Location

Saint Joseph London

London, Kentucky, 40741, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States

Location

Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

New Ulm Medical Center

New Ulm, Minnesota, 56073, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

Location

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092, United States

Location

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

Location

Truman Medical Centers

Kansas City, Missouri, 64108, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina, 29910, United States

Location

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

MGC Hematology Oncology-Union

Union, South Carolina, 29379, United States

Location

Ascension Southeast Wisconsin Hospital - Elmbrook Campus

Brookfield, Wisconsin, 53045, United States

Location

Ascension Saint Francis - Reiman Cancer Center

Franklin, Wisconsin, 53132, United States

Location

Ascension Columbia Saint Mary's Hospital Ozaukee

Mequon, Wisconsin, 53097, United States

Location

Ascension Medical Group Southeast Wisconsin - Mayfair Road

Wauwatosa, Wisconsin, 53226, United States

Location

Doctors Cancer Center

Manatí, 00674, Puerto Rico

Location

Centro Comprensivo de Cancer de UPR

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Genetic Profile; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Genetic Background; Genetic Phenomena; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Jens Rueter

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 13, 2022
• Study Start: October 14, 2022
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (70); PR (2)