Hereditary Pancreatic CancergLHSNCT07307664
Increasing Germline Genetic Testing for Patients With Cancer
A study testing Implementation strategies in people with Hereditary Pancreatic Cancer and Conditions or Focus of Study, run by Josh Peterson at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hereditary Pancreatic Cancer, Conditions or Focus of Study, Hereditary Breast Cancer
- What is being tested?
- Implementation strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Jan 2026to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Providers not on the oncology care team
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
Martha Burla, martha.burla1@northwestern.edu
Daniel Blumenthal, daniel.blumenthal@northwestern.edu
- Recruiting
Geisinger
Danville, Pennsylvania, 17822
Victoria Schlieder, schlieder@geisinger.edu
Adam H Buchanan, MS, MPH, CGC
- Recruiting
Atlanta VA Medical Center
Decatur, Georgia, 30033
Abby Sokoloff, abby.sokoloff@va.gov
Jason Vassy, MD, MPH
- Recruiting
Durham VA Medical Center
Durham, North Carolina, 27705
Abby Sokoloff, abby.sokoloff@va.gov
Jason Vassy, MD, MPH
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Abi Colwell, abcolwel@iu.edu
Todd C Skaar, PhD
- Recruiting
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Abby Sokoloff, abby.sokoloff@va.gov
Jason Vassy, MD, MPH
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Kelsey Rodriguez, kelsey.rodriguez@vumc.org
Kyle W Davis, kyle.w.davis@vumc.org
- Recruiting
Orlando VA Medical Center
Orlando, Florida, 32827
Abby Sokoloff, abby.sokoloff@va.gov
Jason Vassy, MD, MPH
- Recruiting
Salisbury VA Health Care System
Salisbury, North Carolina, 28144
Abby Sokoloff, abby.sokoloff@va.gov
Jason Vassy, MD, MPH
- Recruiting
University of Utah Health
Salt Lake City, Utah, 84112
Kensaku Kawamoto, MD, PhD, MHS, kensaku.kawamoto@utah.edu
Kensaku Kawamoto, MD, PhD, MHS
About this study
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.
Read the 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.
- Conditions
- Hereditary Pancreatic Cancer, Conditions or Focus of Study, Hereditary Breast Cancer, Hereditary Colorectal Cancer
- Being tested
- Implementation strategies
- Keywords
- Genomic Risk, Germline Testing, Hereditary Cancer, Learning Health Systems, Genomic Cancer Risk Assessment, Mainstreaming
- Medical subject headings
- Pancreatic carcinoma, familial, Breast Cancer, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation strategiesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Oncology physicians and advanced practice providers | Experimental | 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. Receives: Behavioral: Implementation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Germline Genetic Testing Ordered for Breast Cancer Patients
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
Measured: 48 months
Germline Genetic Testing Ordered for Pancreatic Cancer Patients
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.
Measured: 48 months
Germline Genetic Testing Ordered for Colorectal Cancer Patients
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.
Measured: 48 months
Secondary outcomes (3)
Germline Genetic Testing Completed by Breast Cancer Patients
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.
Measured: 48 months
Germline Genetic Testing Completed by Pancreatic Cancer Patients
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.
Measured: 48 months
Germline Genetic Testing Completed by Colorectal Cancer Patients
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Jan 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The clinical intervention the investigators will study is mainstreaming of germline testing by oncology care teams for adult patients with colorectal cancer diagnosed under age 50, female breast cancer diagnosed under age 66, and pancreatic cancer diagnosed at any age. These cancer diagnoses and age ranges follow evidence-based guidelines describing indications for germline testing for these patients (e.g., the National Comprehensive Cancer Network, American Society of Clinical Oncology-Society of Surgical Oncology).
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josh Peterson
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Josh Peterson, Vanderbilt University Medical Center
- Investigators
- Josh F Peterson, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307664
- Sponsor's protocol ID
- gLHS
- Acronym
- gLHS
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Germline Genetic Testing for Patients With Cancer
- ClinicalTrials.gov ID
- NCT07307664
- Acronym / sponsor ID
- gLHS / gLHS
- Conditions
- Hereditary Pancreatic Cancer, Conditions or Focus of Study, Hereditary Breast Cancer, Hereditary Colorectal Cancer
- Keywords
- Genomic Risk, Germline Testing, Hereditary Cancer, Learning Health Systems, Genomic Cancer Risk Assessment, Mainstreaming
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Josh PetersonUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), National Cancer Institute (NCI)
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The clinical intervention the investigators will study is mainstreaming of germline testing by oncology care teams for adult patients with colorectal cancer diagnosed under age 50, female breast cancer diagnosed under age 66, and pancreatic cancer diagnosed at any age. These cancer diagnoses and age ranges follow evidence-based guidelines describing indications for germline testing for these patients (e.g., the National Comprehensive Cancer Network, American Society of Clinical Oncology-Society of Surgical Oncology).
| Arm | Type | Receives |
|---|---|---|
| Oncology physicians and advanced practice providers | Experimental | Behavioral: Implementation strategiesClinician 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Providers not on the oncology care team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation strategiesWe 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 | Behavioural | Oncology physicians and advanced practice providers |
Primary outcome
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
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.
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.
3 secondary outcomes
Germline Genetic Testing Completed by Breast Cancer Patients
Time frame: 48 months
Germline Genetic Testing Completed by Pancreatic Cancer Patients
Time frame: 48 months
Germline Genetic Testing Completed by Colorectal Cancer Patients
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josh F Peterson, MD, MPH principal investigator
Vanderbilt University Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation strategies in people with Hereditary Pancreatic Cancer and Conditions or Focus of Study, run by Josh Peterson at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan He, PhD (615-875-9641, megan.he@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Germline Genetic Testing Ordered for Breast Cancer Patients (time frame: 48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.