Bladder Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Metastatic Cancer, Solid Tumor Malignancies
Conditions
Keywords
next-generation sequencing (NGS), expert review of NGS, precision oncology, precision oncology navigator, genome informed therapy (GIT), biomarker-directed clinical trials
Brief summary
This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers). The purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1/2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.
Detailed description
Despite data supporting a survival benefit in many cancers, rates of NGS testing and subsequent GIT are reported to be low in real-world data sets. Rates of multigene panel-based testing and targeted therapy use are reported to be higher at NCI-designated cancer centers compared to other practice types, even when they are associated with a "hub" site. Molecular tumor boards have demonstrated improvements in overall survival in lung cancer, but these models rely on consults being placed by treating physicians and/or significant institutional resources. Many studies evaluating interventions to increase the use of genome informed therapy (GIT) focus on a single cancer type, thereby hindering the ability to operationalize supportive interventions broadly across all cancer types. Given the collective body of data supporting meaningful clinical improvements when patients have access to GIT, we want to study if interventions that make NGS test ordering and interpretation easier for clinicians will increase the rate of orders for GIT. The use of a centralized precision oncology navigator to facilitate completion of NGS testing, expert clinical review from a clinical pharmacist, and documented clinical decision support embedded in the electronic health record represents a unique and more easily scalable model than full molecular tumor board reviews.
Interventions
OTHERExpert Review
Expert reflexive review of next-generation sequencing (NGS) results will be visible in electronic health records (EPIC) for provider review at the University of North Carolina Health System. Expert review will include recommendations for Genome-informed therapy (GIT), identification of available clinical trials, recommendations for additional testing, and/or referrals for genetic counseling.
OTHERBlood or tissue samples collection.
Blood or tissue samples will be collected for next-generation sequencing (NGS) per standard of care.
OTHERThe Precision Oncology Navigation
The precision oncology navigator will coordinate the collection of blood and /or tissue for next-generation sequencing (NGS), as well as order the NGS if not already ordered. Precision oncology navigator will also assist in NGS financial aid applications, if applicable.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
hybrid decentralized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Inclusion Criteria * Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. * Subjects are willing and able to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at the time of consent. * ECOG or Karnofsky Performance Status of 0-2. * Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer * The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting * A genomic tumor test has not been ordered or has been ordered but not resulted.
Exclusion criteria
• Subjects with an active concurrent malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of genome informed therapy (GIT) orders | 2 years | The rate of genome informed therapy (GIT) orders for Level 1/2 GIT will be compared against an estimated baseline historical GIT order. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 2 years | Overall survival of enrolled patients who receive precision oncology navigation order facilitation and reflexive expert review of their Next Generation Sequencing (NGS) result reporting to the date of death for any cause. |
| The rate of genome informed therapy (GIT) orders by site | 2 years | The rate of orders for Level 1/2 genome informed therapy (GIT) at each site. |
| The rates of consent to UNC Health biomarker-selective clinical trials | 2 years | The rates of consent to the University of North Carolina (UNC) Health biomarker-selective clinical trial will be calculated. A subgroup analysis of rates of consent by site may be performed. |
| The reasons for non-consent | 2 years | Among enrolled patients, if a biomarker-selective clinical trial is identified on expert review of Next Generation Sequencing (NGS) results, reasons for non-consent will be collected. |
| Overall Survival in subjects who are eligible for Level 1/2 genome-informed therapy (GIT) | 2 years | To determine the overall survival (OS) after the return of Next Generation Sequencing (NGS) results in those deemed eligible for Level 1/2 genome-informed therapy (GIT) in patients who receive precision oncology navigator order facilitation and reflexive expert review of results. |
| The rates of referrals for full Molecular Tumor Board | 2 years | The rates of referrals for full Molecular Tumor Board review in patients who receive precision oncology navigator order facilitation and reflexive expert review of results will be calculated. |
| The combined rate of orders for Level 1/2 GIT and consent to biomarker-directed clinical trials | 2 years | To determine the combined rate of orders for Level 1/2 genome-informed therapy (GIT) and consent to biomarker-directed clinical trials open at UNC. Health site in patients who receive precision oncology navigator order facilitation and reflexive expert review of results. |
| The time between the date of NGS results and the Level 1/2 GIT order date | 2 years | The time between the date of Next Generation Sequencing (NGS) results and the order date of Level 1/2 GIT will be calculated for those with GIT orders and reported by the site. The median time will be reported for enrolled patients. |
| Reasons for lack of Level 1/2 GIT orders in eligible subjects | 2 years | Reasons why patients deemed eligible for Level 1/2 genome-informed therapy (GIT) by expert review do not have orders for GIT will be collected. |
Countries
United States
Contacts
CONTACTStephanie Drotts
CONTACTDouglas Kirk
PRINCIPAL_INVESTIGATORCarrie Lee
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed