Genomic Tumor Board Review for Cancer

Recruiting at 73 trial locations

Overseen By Dana Sparks

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Southwest Oncology Group

Disqualifiers: Hospice care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

1284 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with your doctor to understand how your current treatments might interact with the study.

What data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model, Genomic Profile, Genomic Tumor Test, Genomic Testing, Tumor Board Review, Genomic Tumor Board Review, Educationally Enhanced Genomic Tumor Board (EGTB) Intervention for cancer?

Research shows that molecular tumor boards (MTBs) can effectively interpret genomic test results and provide expert recommendations, which can improve patient care by offering targeted therapies and clinical guidance. In community settings, MTBs have been shown to provide actionable recommendations for cancer treatment, with a significant portion being implemented by treating physicians. ^{1 2 3 4 5}

Is genomic tumor board review safe for humans?

The research articles do not provide specific safety data for genomic tumor board reviews, but they focus on how these boards help interpret genomic test results for cancer care. ^{1 2 6 7 8}

How is the Genomic Tumor Board Review treatment different from other cancer treatments?

The Genomic Tumor Board Review treatment is unique because it involves a team of experts analyzing a patient's tumor genetic profile to provide personalized treatment recommendations, which is not typically part of standard cancer treatments. This approach allows for precision medicine, tailoring treatments based on specific genetic alterations in the tumor. ^{1 2 3 9 10}

Research Team

Jens Rueter

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with stage III or IV solid tumors that are recurrent, relapsed, refractory, metastatic, or newly diagnosed and advanced. Participants must be under the care of a study-enrolled physician and have genomic tumor tests ordered but not yet received results. They should not be on hospice care and must consent to participate.

Inclusion Criteria

My doctor ordered a genomic tumor test for me less than a week ago, and I'm waiting for the results.

Physician participants must be board-eligible or board-certified in Medical Oncology, Gynecologic Oncology, or Neurology

Participants must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

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

Recruitment Centers must not have or utilize an existing Genomic Tumor Board

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either usual care or the EGTB intervention, which includes genomic tumor board sessions and supporting education.

6 months

Weekly GTB sessions (virtual) for Arm 2

Follow-up

Participants are monitored for clinical outcomes, including survival and treatment discontinuation.

24 months

Treatment Details

Interventions

• Educational Intervention
• Genomic Profile
• Tumor Board Review

Trial Overview The trial examines if an educationally enhanced genomic tumor board (EGTB) can increase genome-informed treatment in patients with serious solid tumors. It compares usual review methods of genomic test results against those reviewed by a GTB—a team experienced in interpreting genetic changes—to improve treatment decisions.

Participant Groups

Group I: Arm 2 (EGTB) Experimental Treatment 6 Interventions

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.

Group II: Arm 1 (usual care) Active Control 5 Interventions

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

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The study evaluated the concordance of treatment recommendations from molecular tumor boards (MTBs) across 12 leading cancer institutions in Japan, finding an overall concordance rate of 62% with centrally developed consensus recommendations based on 50 simulated cancer cases.

Concordance was notably higher for cases with established biomarkers, such as colorectal cancer and ROS1 fusion (100%), while it was significantly lower for cervical cancer and cases with TP53 mutations, indicating a need for improved information sharing on treatments for genomic alterations with low evidence levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concordance Between Recommendations From Multidisciplinary Molecular Tumor Boards and Central Consensus for Cancer Treatment in Japan. Naito, Y., Sunami, K., Kage, H., et al.[2023]

The Breast Multidisciplinary Genomic Tumor Board (MGTB) effectively reviewed genomic test results for 40 metastatic breast cancer patients, primarily recommending clinical trials and FDA-approved therapies, showcasing the potential of multidisciplinary collaboration in cancer care.

While the MGTB provided more precise care recommendations, challenges included the limited actionability of genomic results and the dominance of medical oncologists in decision-making, highlighting areas for improvement in interdisciplinary contributions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"A rising tide lifts all boats": establishing a multidisciplinary genomic tumor board for breast cancer patients with advanced disease. McGowan, ML., Ponsaran, RS., Silverman, P., et al.[2018]

A community-based molecular tumor board (MTB) effectively processed genomic profiling results for 613 cancer patients, providing 837 actionable treatment recommendations, including standard therapies and clinical trials.

Implementation rates of these recommendations were significant, with 36% to 78% being followed by physicians, and 13% of patients enrolling in clinical trials based on MTB suggestions, demonstrating the MTB's role in enhancing patient management in advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of a Molecular Tumor Board (MTB) and Uptake of Recommendations in a Community Setting. VanderWalde, A., Grothey, A., Vaena, D., et al.[2020]

In a study involving 328 cancer patients discussed in multidisciplinary tumor boards (MTBs), 60.7% of cases resulted in a recommended change in clinical management, highlighting the significant impact of MTBs on treatment decisions.

Compliance with MTB recommendations for changing clinical management was 58.5%, indicating that while MTBs provide valuable insights into targeted therapies, there is still room for improvement in implementing these recommendations in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Molecular Tumor Board on the Clinical Management of Patients With Cancer. Behel, V., Noronha, V., Choughule, A., et al.[2022]

Molecular tumor boards (MTBs) in The Netherlands are consistently structured and show a high level of agreement (86%) in treatment recommendations for patients with rare or complex mutational cancer profiles, indicating their effectiveness in guiding targeted therapies.

The study suggests a 'Dutch MTB model' that promotes collaboration and data sharing among institutions, which could enhance the quality and consistency of treatment recommendations across different cancer centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Comparison of Molecular Tumor Boards in The Netherlands: Definition, Composition, Methods, and Targeted Therapy Recommendations. Koopman, B., Groen, HJM., Ligtenberg, MJL., et al.[2021]

A study involving 58 community oncology physicians revealed that while they generally have moderate confidence in using large-panel genomic tumor testing (GTT), they feel less confident about patients' understanding of test results and accessing targeted treatments.

Clinicians' intentions to use GTT in the future are linked to their confidence in using the tests and their perceptions of barriers to implementation, rather than their attitudes towards the value of GTT, indicating a need for further research on factors influencing GTT adoption in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community oncologists' perceptions and utilization of large-panel genomic tumor testing. Anderson, EC., Hinton, AC., Lary, CW., et al.[2023]

A study involving 12 patients highlighted significant gaps in understanding tumor genomic testing (TGT), particularly among lower-income and minority groups, indicating a need for better education on the subject.

To address these gaps, a concise animated video was developed to improve patient education about TGT, covering its implications for treatment, the testing process, insurance coverage, and the potential for incidental germline findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Understanding of Tumor Genomic Testing: A Quality Improvement Effort. Senter, L., Veney, D., Surplus, T., et al.[2023]

In a study involving 43 patients with advanced breast cancer, 93% had at least one actionable genetic mutation identified through genomic profiling, highlighting the potential for personalized treatment options.

Of the patients discussed in the Molecular Tumor Board, 16% were treated based on the findings, with 41% of those achieving stable disease or partial remission, indicating that multidisciplinary approaches can enhance treatment strategies, though access to targeted therapies remains a significant barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer Experience of the Molecular Tumor Board at the University of California, San Diego Moores Cancer Center. Parker, BA., Schwaederlé, M., Scur, MD., et al.[2022]

A systematic review of 14 studies involving 3,328 cancer patients indicated that molecular tumor board (MTB) reviews can lead to improved clinical outcomes, particularly for patients with limited standard treatment options.

In a controlled trial, patients receiving therapy recommended by the MTB showed significantly better progression-free survival compared to those on conventional therapies, suggesting that MTB recommendations may enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Molecular Tumor Boards: A Systematic Review. Larson, KL., Huang, B., Weiss, HL., et al.[2022]

Precision cancer medicine focuses on individualized treatment based on specific gene alterations in tumors, which can significantly impact treatment effectiveness.

The establishment of a molecular tumor board (MTB) and clinical tumor board (CTB) system helps physicians interpret genetic profiling results and make informed treatment recommendations, addressing the challenge of integrating genetic information into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of Cancer Genomic Board and Preparation of Genomic Report]. Nakamura, K., Nishihara, H.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Concordance Between Recommendations From Multidisciplinary Molecular Tumor Boards and Central Consensus for Cancer Treatment in Japan. [2023]

2. England pubmed.ncbi.nlm.nih.gov

"A rising tide lifts all boats": establishing a multidisciplinary genomic tumor board for breast cancer patients with advanced disease. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Establishment of a Molecular Tumor Board (MTB) and Uptake of Recommendations in a Community Setting. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Molecular Tumor Board on the Clinical Management of Patients With Cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Multicenter Comparison of Molecular Tumor Boards in The Netherlands: Definition, Composition, Methods, and Targeted Therapy Recommendations. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Community oncologists' perceptions and utilization of large-panel genomic tumor testing. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Patient Understanding of Tumor Genomic Testing: A Quality Improvement Effort. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer Experience of the Molecular Tumor Board at the University of California, San Diego Moores Cancer Center. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Molecular Tumor Boards: A Systematic Review. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

[Management of Cancer Genomic Board and Preparation of Genomic Report]. [2020]