Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting

NCT03804255 | Withdrawn DMC

• 4 other identifiers: EAQ161CDNCI-2018-01707ECOG-ACRIN-EAQ161CDUG1CA189828
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Colorectal Carcinoma; Community Practice; Lung Carcinoma; Melanoma; Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• Presence of reflexive testing protocols for guideline-recommended biomarkers

  Defined as standing protocols that do not require an oncologist order for each of the following: 1) EGFR and ALK testing in lung cancer; 2) KRAS testing in colorectal cancer; 3) BRAF testing in melanoma; and 4) HER2 testing in breast cancer. Will itemize each guideline recommendation and determine whether each pathology practice has reflexive testing protocols through self-report on the assessment. The proportion of pathology practices and exact 95% two-sided confidence intervals with reflexive-testing protocols will be calculated.

  Up to 9 months

• Average turnaround time of no more than 10 business days for combined EGFR and ALK results reporting in lung cancer

  The pathology practices will indicate the average number of business days between the day the tumor tissue is available and the day that all the test results are reported to the physician. Pathology practices will be considered meeting guidelines if the average is less than or equal to 10 days. The proportion of pathology practices and exact 95% two-sided confidence intervals with average turnaround time within 10 business days will be calculated.

  Up to 9 months

• 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

  For each biomarker-cancer combination being investigated, univariate and multivariate logistic regression modelling will be performed. There will be variables collected at the oncology component/subcomponent level and variables collected at the pathology practice level. The analysis will be completed at the level of the pathology practice, so characteristics of the oncology component/subcomponent will have to be adapted to that of the pathology practice: repeated for all of pathology practices used by one oncology component/subcomponent, or consolidated for pathology practices that service multiple oncology component/subcomponent. Variables used to assess heterogeneity will be (a) component/subcomponent characteristics: geography (census region), size (number of adult oncology beds), safety-net hospital, minority/underserved National Cancer Institute (NCI) Community Oncology Research Program (NCORP) component/subcomponent, academic hospital, public-ownership type.

  Up to 9 months

Secondary Outcomes (7)

• Use of genotyping or broad molecular profiling/next generation tumor sequencing for EGFR and ALK testing in lung cancer

  Up to 9 months

• Use of MMR protein expression testing by immunohistochemistry (IHC) or microsatellite instability (MSI) in colorectal cancer

  Up to 9 months

• Capacity to test for cMET or PTEN in lung cancer

  Up to 9 months

• Capacity to test for HRAS, AKT1, PTEN or PIK3CA in colorectal cancer

  Up to 9 months

• Reason for testing novel biomarkers (used for clinical care, clinical trials, or both)

  Up to 9 months

Study Arms (1)

Observational (survey)

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

Other: Survey Administration

Interventions

Survey Administration OTHER

Complete surveys

Observational (survey)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Onsite pathology practices within NCORP components and subcomponents that provide services to adult oncology groups

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• ECOG-ACRIN Cancer Research Group: lead

Study Sites (1)

Center for Business Models in Healthcare

Chicago, Illinois, 60625, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• Julia Trosman

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 15, 2019
• Study Start: January 8, 2019
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)