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Increasing Germline Genetic Testing for Patients With Cancer

Study acronym: gLHS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Site details revised at 2 of 10 sitesv5
  2. Minor Site details revised at 6 of 10 sitesv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2026 to Jan 30, 2026
    • Site details revised at 10 of 10 sites
    v3
  4. Minor Study description expanded, about 2 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Germline testing for hereditary cancer syndromes is underutilized across most health care settings. Using a learning health care approach, the Genomics-enabled Learning Health Systems (gLHS) network aims to evaluate the impact of a suite of implementation strategies to increase germline test ordering by oncology care teams (i.e., mainstreaming) for eligible patients with breast, pancreatic or colorectal cancer. Secondarily, the study will investigate completion of testing by eligible patients, as well as impact on overall rates of germline test ordering in patients with cancer. The network will bundle and deploy different implementation strategies across the clinical sites in three 6-month phases. A maintenance phase after the implementation periods will measure genetic testing rates without any additional implementation strategies to determine persistence of effects. The implementation strategies address clinician-level factors, and thus oncologists and their team members (e.g. advanced practice providers, nurse navigators, case managers) will be the focus of evaluating the impact of implementation strategies. Strategies that will be considered include provider education, audit and feedback reports, facilitation, peer support, and electronic health record (EHR) system optimization to support germline testing. Using the RE-AIM QuEST framework, outcomes will be assessed using mixed methods separately for each eligible cancer type. Data collection from the EHR, other relevant data sources, and qualitative provider feedback will be used to assess ordering and completion of tests and the effect of the implementation strategies on germline testing rates in oncology clinics.
Trial Details
NCT Number NCT07307664
Lead Sponsor Josh Peterson
Collaborators: National Human Genome Research Institute (NHGRI), National Cancer Institute (NCI)
Conditions
(from sponsor)
Hereditary Pancreatic Cancer, Conditions or Focus of Study, Hereditary Breast Cancer, Hereditary Colorectal Cancer
Related terms Breast Cancer, Familial, Pancreatic carcinoma, familial
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov