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

Plain English Summary

Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting is a Not Applicable clinical trial sponsored by ECOG-ACRIN Cancer Research Group studying Breast Carcinoma, Colorectal Carcinoma, Community Practice, Lung Carcinoma, Melanoma, Solid Neoplasm. This trial examines how cancer biomarker tests are currently used in community cancer centers. It is designed for pathology practices within cancer research networks that serve adult oncology patients. Participation involves completing surveys about testing procedures and practices. There are no direct patient alternatives as this is a study of existing practices, not a treatment trial.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Pathology practices within specific cancer research networks (NCORP) that serve adult cancer patients. Practices must be financially managed and operated by the NCORP component, not commercial labs. An individual from the pathology practice must be willing to provide information. This study does not involve direct patient participation or eligibility criteria for patients. This trial is studying Breast Carcinoma, Colorectal Carcinoma, Community Practice, Lung Carcinoma, Melanoma, Solid Neoplasm, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how often recommended biomarker tests are performed, how quickly results are returned, and what factors affect the availability of these tests, all of which impact how qui The specific primary outcome measures are: Presence of reflexive testing protocols for guideline-recommended biomarkers (Up to 9 months); Average turnaround time of no more than 10 business days for combined EGFR and ALK results reporting in lung cancer (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 (Up to 9 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it aims to identify and improve the quality and consistency of biomarker testing, which is crucial for guiding cancer treatment decisions in everyday clinical practice. This research targets Breast Carcinoma, Colorectal Carcinoma, Community Practice, Lung Carcinoma, Melanoma, Solid Neoplasm, where improved treatment options are needed.

Investor Insight

This observational study, though withdrawn, aimed to understand the infrastructure for precision oncology in community settings, a critical step for assessing the market readiness and potential for ne

Is This Trial Right for Me?

Patients should ask their doctors if biomarker testing is being done for their specific cancer and how it will guide their treatment. Understanding the results of biomarker tests is important for discussing treatment options with your doctor. This trial does not directly involve patients in treatment, but its findings could lead to better testing processes for future patients. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL

Interventions

• OTHER: Survey Administration — Complete surveys

Primary Outcomes

• Presence of reflexive testing protocols for guideline-recommended biomarkers (Up to 9 months)
• Average turnaround time of no more than 10 business days for combined EGFR and ALK results reporting in lung cancer (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 (Up to 9 months)

Secondary Outcomes

• 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)

Full 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.

Trial Locations

• Center for Business Models in Healthcare, Chicago, Illinois, United States

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Melanoma
• Solid Tumors
• Oncology
• Precision Medicine
• Biomarker Testing
• Pathology
• Community Oncology

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