Make germline genetic testing easier for people with breast, pancreatic, or colorectal cancer
Increasing Germline Genetic Testing for Patients With Cancer
NA · Vanderbilt University Medical Center · NCT07307664
This project tries a set of clinic changes to see if oncology teams will order more germline genetic tests for people with breast, pancreatic, or colorectal cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT07307664 on ClinicalTrials.gov |
What this trial studies
The Genomics-enabled Learning Health Systems network will deploy a bundled set of implementation strategies aimed at ‘mainstreaming’ germline testing so oncology care teams can directly order tests. Different strategy bundles will be rolled out across participating VA sites in three consecutive 6-month phases, followed by a maintenance phase to see whether effects persist without extra support. Primary outcomes include rates of guideline-concordant test ordering by clinicians and secondary outcomes include patient completion of testing and overall testing rates. The interventions target clinician- and workflow-level factors rather than individual patient treatments.
Who should consider this trial
Good fit: Adults with breast cancer, pancreatic cancer, or colorectal cancer who meet guideline criteria for hereditary (germline) testing are the ideal candidates to benefit from this work.
Not a fit: Patients with cancer types outside breast, pancreatic, or colorectal cancer, those who already had guideline-based germline testing, or those receiving care outside the participating VA sites are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, more patients who meet guidelines could receive germline testing, enabling targeted therapies, earlier surveillance, and cascade testing of family members.
How similar studies have performed: Previous single-site and smaller multisite mainstreaming programs have increased testing uptake, but large multisite learning health system deployments of bundled implementation strategies remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Oncology care team members (including, but not limited to, oncologists, advanced practice providers, nurse navigators, caring for patients with adult patients with breast cancer, pancreatic cancer or colorectal cancer. Exclusion Criteria: * Providers not on the oncology care team
Where this trial is running
Los Angeles, California and 9 other locations
- VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (RECRUITING)
- Orlando VA Medical Center — Orlando, Florida, United States (RECRUITING)
- Atlanta VA Medical Center — Decatur, Georgia, United States (RECRUITING)
- Northwestern Medicine — Chicago, Illinois, United States (NOT_YET_RECRUITING)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (RECRUITING)
- Durham VA Medical Center — Durham, North Carolina, United States (RECRUITING)
- Salisbury VA Health Care System — Salisbury, North Carolina, United States (RECRUITING)
- Geisinger — Danville, Pennsylvania, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
- University of Utah Health — Salt Lake City, Utah, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Josh F Peterson, MD, MPH — Vanderbilt University Medical Center
- Study coordinator: Megan He, PhD
- Email: megan.he@vumc.org
- Phone: 615-875-9641
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hereditary Pancreatic Cancer, Conditions or Focus of Study, Hereditary Breast Cancer, Hereditary Colorectal Cancer, Genomic Risk, Germline Testing, Hereditary Cancer, Learning Health Systems