Increasing Germline Genetic Testing for Patients With Cancer (gLHS)

April 2, 2026 updated by: Josh Peterson
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project seeks to close the acknowledged care gap in genetic testing of hereditary cancer predisposition by evaluating implementation strategies expected to increase guideline-concordant germline genetic testing (referred to in protocol as "germline testing" and defined as testing for inherited gene variants related to cancer) by oncology care teams (i.e., 'mainstreaming', or 'task-shifting' from the traditional genetic consultation referral model). Identification of inherited pathogenic variants in individuals with a cancer diagnosis can have implications for treatment, with targeted therapies. Furthermore, identifying individuals with hereditary risk provides an opportunity for surveillance for early detection of other cancers or risk-reducing procedures. Finally, identifying a pathogenic variant allows for cascade testing in family members, extending these benefits to more individuals. Germline testing for hereditary cancer within current clinical practice is underutilized across most health care settings, even though evidence supports effectiveness to inform clinical care. Mainstreaming is service delivery model that has emerged to improve access to germline testing. It shifts the clinical activities of pre- and post- test germline testing to frontline clinician teams. Here, the investigators will be studying the implementation of mainstreaming throughout the germline testing process, from recognizing patients who are eligible for germline testing to disclosing results for those who opt to test.

The study will assess changes in germline test orders for and completion by patients with cancer who receive care across the clinical sites in the gLHS Network before and after deploying implementation strategies designed to promote testing uptake. There will be three implementation phases followed by a maintenance period. The selected implementation strategies are widely used to improve clinical practice and address barriers previously reported in the literature and documented in participating sites. These strategies will aim to increase mainstreaming of germline testing by oncology teams. Most studies evaluating mainstreaming of germline testing for cancer have been performed in relatively small numbers of patients often at single institutions focusing on outcomes of feasibility and patient and provider satisfaction. Implementation outcomes (e.g., reach, adoption, implementation) precede and impact both service and patient outcomes. Thus, understanding implementation outcomes for mainstreaming of germline testing, as well as contextual factors that are associated with successful implementation, is fundamental to achieving high-quality genetic health care.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • Recruiting
        • VA Greater Los Angeles Healthcare System
        • Principal Investigator:
          • Lori Orlando, MD
        • Principal Investigator:
          • Deepak Voora, MD
        • Contact:
        • Principal Investigator:
          • Jason Vassy, MD, MPH
        • Principal Investigator:
          • Maren Scheuner, MD, MPH
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Orlando VA Medical Center
        • Principal Investigator:
          • Lori Orlando, MD
        • Principal Investigator:
          • Deepak Voora, MD
        • Contact:
        • Principal Investigator:
          • Jason Vassy, MD, MPH
        • Principal Investigator:
          • Maren Scheuner, MD, MPH
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Principal Investigator:
          • Lori Orlando, MD
        • Principal Investigator:
          • Deepak Voora, MD
        • Contact:
        • Principal Investigator:
          • Jason Vassy, MD, MPH
        • Principal Investigator:
          • Maren Scheuner, MD, MPH
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia D Franklin, MD, MPH, MBA
        • Principal Investigator:
          • Rinad S Beidas, PhD
        • Principal Investigator:
          • Elizabeth M McNally, MD, PhD
        • Principal Investigator:
          • Lucy A Godley, MD, PhD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
        • Principal Investigator:
          • Todd C Skaar, PhD
        • Principal Investigator:
          • Paul R Dexter, MD
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham VA Medical Center
        • Principal Investigator:
          • Lori Orlando, MD
        • Principal Investigator:
          • Deepak Voora, MD
        • Contact:
        • Principal Investigator:
          • Jason Vassy, MD, MPH
        • Principal Investigator:
          • Maren Scheuner, MD, MPH
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Salisbury VA Health Care System
        • Principal Investigator:
          • Lori Orlando, MD
        • Principal Investigator:
          • Deepak Voora, MD
        • Contact:
        • Principal Investigator:
          • Jason Vassy, MD, MPH
        • Principal Investigator:
          • Maren Scheuner, MD, MPH
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger
        • Contact:
        • Principal Investigator:
          • Adam H Buchanan, MS, MPH, CGC
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Dan Roden, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexander G Bick, MD, PhD
        • Principal Investigator:
          • Sunil Kripalani, MD, MSc
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • University of Utah Health
        • Principal Investigator:
          • Martin Tristani-Firouzi, MD
        • Contact:
        • Principal Investigator:
          • Kensaku Kawamoto, MD, PhD, MHS
        • Principal Investigator:
          • Mark Yandell, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oncology physicians and advanced practice providers
Clinician members of oncology teams who care for adults with breast, pancreatic, or colorectal cancer will be the target population. We will assess changes in germline test orders for and completion by patients before and after deploying implementation strategies designed to promote testing uptake.
Behavioral: Implementation strategies

We will deploy different strategy bundles across the clinical sites in three approximate 6-month phases.

Phase I - Facilitation of provider training, educational materials, and information resources; Patient-facing educational material and information resources Phase II - Audit and feedback report on existing patients; Practice champion support; Optimizing EHR strategies Phase III - EHR tools to facilitate prospective identification of patients, testing, and result reporting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Germline Genetic Testing Ordered for Breast Cancer Patients
Time Frame: 48 months
Number of eligible breast cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible breast cancer patients seen by the oncology team
48 months
Germline Genetic Testing Ordered for Pancreatic Cancer Patients
Time Frame: 48 months
Number of eligible pancreatic cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible pancreatic cancer patients seen by the oncology care team.
48 months
Germline Genetic Testing Ordered for Colorectal Cancer Patients
Time Frame: 48 months
Number of eligible colorectal cancer patients with germline genetic testing ordered by an oncology care team provider, or associated with an oncology visit, within 7 days of an oncology encounter divided by the number of eligible colorectal cancer patients seen by the oncology care team.
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Germline Genetic Testing Completed by Breast Cancer Patients
Time Frame: 48 months
Number of eligible breast cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible breast cancer patients with an order placed by the oncology care team determined by EHR data extraction.
48 months
Germline Genetic Testing Completed by Pancreatic Cancer Patients
Time Frame: 48 months
Number of eligible pancreatic cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible pancreatic cancer patients with an order placed by the oncology care team determined by EHR data extraction.
48 months
Germline Genetic Testing Completed by Colorectal Cancer Patients
Time Frame: 48 months
Number of eligible colorectal cancer patients completing germline testing order that was placed by their oncology care team divided by the number of eligible colorectal cancer patients with an order placed by the oncology care team determined by EHR data extraction.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josh Peterson

Collaborators

National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Josh F Peterson, MD, MPH, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gLHS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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