Clinical trial NCT03804255: Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting
Official title: Biomarker Testing in Common Solid Cancers: An Assessment of Current Practices in Precision Oncology in the Community Setting
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Carcinoma
Colorectal Carcinoma
Community Practice
Lung Carcinoma
Melanoma
Solid Neoplasm
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-01-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Onsite pathology practices within NCORP components and subcomponents that provide services to adult oncology groups

Brief summary: This trial assesses current biomarker testing practices for common solid cancers in precision oncology in the community setting. Cancer biomarkers are used for diagnosing the disease, determining prognosis, predicting response to a targeted therapy, or monitoring response to therapy. Testing quality, including accuracy and timeliness, is imperative for correct disease prognosis and identification of patients who may or may not benefit from a targeted therapy. Assessing current biomarker testing practices may help doctors identify gaps and variations in testing as well as on potential ?best practices? that may be informative and generalizable to community oncology programs.

Detailed description: PRIMARY OBJECTIVES:

I. Determine capacity of pathology practices within National Cancer Institute (NCI) Community Oncology Research Program (NCORP) components/subcomponents for testing guideline-recommended biomarkers, including whether these biomarkers are tested, and how, i.e. what technologies are used and what ordering and testing processes / protocols have been implemented.

II. Determine capacity for testing for novel biomarkers and tumor molecular profiling, i.e. whether these biomarkers are tested and how, i.e. what technologies are used what ordering and testing processes/protocols have been implemented.

III. For findings in Objectives 1 and 2, determine factors influencing the heterogeneity of capacity for biomarker testing, particularly those factors that are modifiable (based on the conceptual framework above), such as cost, complexity, technologic complexity, lack of familiarity, physician and patient demand.

OUTLINE:

Participants complete a self-administered web-based Biomarker Survey and may also complete an Outcome Validation Survey.

Eligibility criteria: Inclusion Criteria:

* The study population is all onsite pathology practices within NCORP components and subcomponents that provide services to adult oncology groups.
* An onsite pathology practice is a laboratory (lab) that is financially administered and operated by an NCORP component or subcomponent. This excludes commercial reference laboratories, such as Quest and LabCorp. To describe biomarker testing practices across NCORP components/subcomponents, we will use the pathology practice as the unit of analysis. Participating components/subcomponents should meet \[element A\] AND \[at least one element of B OR C OR D\] AND element E.

  * A) NCORP component/subcomponent provides services to adult oncology groups.
  * B) A single onsite pathology lab (and its set of testing practices), may provide biomarker/pathology testing services to one or more components or subcomponents. Irrespective of the number of components/subcomponents that use this pathology lab, we will consider this as one pathology practice, and one unit of analysis.
  * C) Several onsite pathology labs may provide services to one NCORP component or subcomponent, e.g. if the NCORP component or subcomponent represents a health system with several hospitals, and each hospital may have its own onsite pathology lab, with each pathology lab following its own set of testing practices. Therefore, each lab will represent one pathology practice and one unit of analysis.
  * D) More than one onsite pathology lab may use a common set of testing practices and provide services to one or more NCORP components or subcomponents. Given common testing practices, we will consider these labs as one pathology practice, and one unit of analysis.
  * E) The pathology practice has an informed individual who is willing to serve as a representative and gather information to complete the assessment items. This person typically is the pathology practice medical director, pathology practice administrative director and/or their designees.

Primary outcomes:
measure: Presence of reflexive testing protocols for guideline-recommended biomarkers
timeFrame: Up to 9 months
measure: Average turnaround time of no more than 10 business days for combined EGFR and ALK results reporting in lung cancer
timeFrame: Up to 9 months
measure: Factors influencing heterogeneity of capacity for biomarker testing, from among modifiable testing practice-related factors, e.g. cost, complexity, technologic complexity, lack of familiarity, physician and patient demand
timeFrame: Up to 9 months
Secondary outcomes:
measure: Use of genotyping or broad molecular profiling/next generation tumor sequencing for EGFR and ALK testing in lung cancer
timeFrame: Up to 9 months
measure: Use of MMR protein expression testing by immunohistochemistry (IHC) or microsatellite instability (MSI) in colorectal cancer
timeFrame: Up to 9 months
measure: Capacity to test for cMET or PTEN in lung cancer
timeFrame: Up to 9 months
measure: Capacity to test for HRAS, AKT1, PTEN or PIK3CA in colorectal cancer
timeFrame: Up to 9 months
measure: Reason for testing novel biomarkers (used for clinical care, clinical trials, or both)
timeFrame: Up to 9 months
measure: Number of days between sample availability and report availability for all biomarkers tested
timeFrame: Up to 9 months
measure: Proportion of pathology practices testing for novel biomarkers using a standard reflexive testing protocol
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Business Models in Healthcare
state: Illinois
Study officials:
affiliation: ECOG-ACRIN Cancer Research Group
name: Julia Trosman
role: PRINCIPAL_INVESTIGATOR
References: