Genetic Testing for Cancer

(gLHS Trial)

Not yet recruiting at 9 trial locations
MH
LA
Overseen ByLynn A Seabolt, MS, RD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Josh Peterson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase genetic testing to identify hereditary cancer risks in patients with breast, pancreatic, or colorectal cancer. It focuses on improving the frequency with which doctors and their teams order these tests and the number of patients who complete them. The trial will evaluate several strategies, such as educating doctors and enhancing electronic health records, to determine which most effectively boosts test usage. It suits patients with these cancers who wish to explore genetic testing options. As an unphased trial, it allows patients to contribute to research that could enhance genetic testing practices and potentially benefit future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on genetic testing strategies for cancer care teams, not on patient medication changes.

What prior data suggests that these implementation strategies are safe for increasing germline genetic testing?

Research has shown that germline genetic testing, which identifies inherited cancer risks, is generally safe. One study in a medical journal found that although testing after a cancer diagnosis is uncommon, it poses no major health risks.

The goal is to increase the use of this testing to help people better understand their cancer risks. The strategies under evaluation aim to simplify the process for doctors and their teams to order these tests. This includes enhanced training and improvements to electronic health records to support testing. Overall, the process is safe and seeks to help more people learn about their genetic risks for cancer.1234

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on increasing the use of germline genetic testing among patients with breast, pancreatic, or colorectal cancer. Unlike standard treatments that primarily focus on managing cancer symptoms or slowing progression, genetic testing offers a personalized approach by identifying inherited mutations that may influence treatment decisions and outcomes. This method empowers both patients and clinicians to tailor treatment strategies more effectively, potentially leading to better-targeted therapies and improved patient care.

What evidence suggests that these implementation strategies are effective for increasing germline genetic testing in cancer patients?

This trial will focus on increasing germline genetic testing among oncology physicians and advanced practice providers who care for adults with breast, pancreatic, or colorectal cancer. Studies have shown that increasing genetic testing for inherited traits can significantly raise testing rates among cancer patients. For example, one study found that 90% of participants completed the genetic test when efforts encouraged testing. Making this testing a regular part of care has also proven successful, with over 32,000 tests completed, including nearly 12,000 through this approach. Despite the benefits, genetic testing remains underutilized, with only a small percentage of cancer patients receiving this recommended test. These findings suggest that strategies to increase testing can effectively address this important gap in care.14567

Who Is on the Research Team?

JF

Josh F Peterson, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with breast, pancreatic, or colorectal cancer who may benefit from germline genetic testing to identify hereditary cancer syndromes like BRCA mutations and Lynch syndrome. The focus is on increasing test ordering by oncology care teams.

Inclusion Criteria

Oncology care team members caring for adult patients with breast cancer, pancreatic cancer, or colorectal cancer

Exclusion Criteria

Providers not on the oncology care team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Phase 1

Deployment of initial implementation strategies to increase germline test ordering by oncology care teams

6 months

Implementation Phase 2

Continuation and adjustment of implementation strategies based on initial phase outcomes

6 months

Implementation Phase 3

Final phase of implementation strategies to maximize germline test ordering and completion

6 months

Maintenance

Measurement of genetic testing rates without additional implementation strategies to determine persistence of effects

6 months

Follow-up

Participants are monitored for the persistence of germline testing rates and outcomes

48 months

What Are the Treatments Tested in This Trial?

Interventions

  • Increasing Germline Genetic Testing

Trial Overview

The study tests a set of strategies to encourage oncologists and their teams to order genetic tests more often. These include education, feedback reports, facilitation, peer support, and optimizing electronic health records.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Oncology physicians and advanced practice providersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Josh Peterson

Lead Sponsor

National Human Genome Research Institute (NHGRI)

Collaborator

Trials
273
Recruited
299,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Increasing Germline Genetic Testing for Patients With Cancer

This project seeks to close the acknowledged care gap in genetic testing of hereditary cancer predisposition by evaluating implementation ...

Improving uptake of germline genetic testing amongst ...

Study-wide, an incredible 90% completed genetic testing, with a statistically significantly higher rate of genetic testing uptake amongst those ...

Expanding Germline Hereditary Cancer Gene Panel ...

Over 32,000 germline hereditary cancer gene panels were completed, including nearly 12,000 tests through mainstreaming. Mainstreaming resulted ...

Few People with Cancer Undergo Germline Testing - NCI

Only a small percentage of people diagnosed with cancer undergo a type of genetic testing, called germline testing, that is highly recommended for those ...

Germline Genetic Testing After Cancer Diagnosis

Germline genetic testing after cancer diagnosis was low (6.8%; n = 93 052). Testing was highest in males with breast cancer (50%) and in patients with ovarian ...

Universal Germline Genetic Testing for Hereditary Cancer ...

Here, we discuss the current evidence that challenges these assumptions and supports the implementation of universal HCS testing among patients with solid ...

Selection of Germline Genetic Testing Panels in Patients ...

These multigene panels include genes in which pathogenic or likely pathogenic variants confer a high relative risk of cancer (BRCA1/2 and Lynch ...