Recruiting

Germline Testing

Sponsor:

Josh Peterson

Code:

NCT07307664

Conditions

Hereditary Pancreatic Cancer

Conditions or Focus of Study

Hereditary Breast Cancer

Hereditary Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Implementation strategies

Study Details

Brief summary:

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.

Conditions

Hereditary Pancreatic Cancer

Conditions or Focus of Study

Hereditary Breast Cancer

Hereditary Colorectal Cancer

Study ID

NCT07307664

Start date

Jan 30, 2026

Status verified date

Jun, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Germline Genetic Testing Ordered for Breast Cancer Patients [ Time Frame: 48 months ]
  • Germline Genetic Testing Ordered for Pancreatic Cancer Patients [ Time Frame: 48 months ]
  • Germline Genetic Testing Ordered for Colorectal Cancer Patients [ Time Frame: 48 months ]

Central Contacts and Locations

Central contacts

Locations

VA Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 90073

Contacts

Principal Investigator:

Jason Vassy, MD, MPH

Orlando VA Medical Center

Recruiting

Orlando, Florida, United States, 32827

Contacts

Principal Investigator:

Jason Vassy, MD, MPH

Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Principal Investigator:

Jason Vassy, MD, MPH

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Patricia D Franklin, MD, MPH, MBA

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Abi Colwell

abcolwel@iu.edu

Principal Investigator:

Todd C Skaar, PhD

Durham VA Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Jason Vassy, MD, MPH

Salisbury VA Health Care System

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Principal Investigator:

Jason Vassy, MD, MPH

Geisinger

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Victoria Schlieder

schlieder@geisinger.edu

Principal Investigator:

Adam H Buchanan, MS, MPH, CGC

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Dan Roden, MD

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Kensaku Kawamoto, MD, PhD, MHS

kensaku.kawamoto@utah.edu

Principal Investigator:

Kensaku Kawamoto, MD, PhD, MHS

More Information

Sponsor

Josh Peterson

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Genomic Risk
  • Germline Testing
  • Hereditary Cancer
  • Learning Health Systems
  • Genomic Cancer Risk Assessment
  • Mainstreaming

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Josh Peterson on 2026-06-09.