Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology … (NCT03804255) | Clinical Trial Compass
WithdrawnNot Applicable
Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting
Stopped: Study closed before patients enrolled
United States0Started 2019-01-08
Plain-language 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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial's status shows it was withdrawn before enrolling anyone — do you know why it was pulled, and does that affect how we should think about the biomarker testing questions it was trying to answer?
2Since this study was looking at how consistently community oncology practices run reflex biomarker testing for cancers like mine, can you walk me through what biomarker tests are currently recommended for my specific diagnosis and whether your practice runs them automatically?
3The trial was measuring turnaround time for tests like EGFR and ALK in lung cancer — for my situation, how long should I expect to wait for biomarker results, and could any delays affect when we need to start treatment?
4One of the things this study wanted to understand was why biomarker testing varies between practices — factors like cost and access — so should I be asking whether all the guideline-recommended tests for my cancer type are available here, or whether I need a referral to a larger center?
5Since this was an observational study rather than a treatment trial, and it was withdrawn, are there other ways you're staying current on precision oncology biomarker guidelines for my type of cancer so we're not missing a targeted treatment option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of reflexive testing protocols for guideline-recommended biomarkers
Timeframe: Up to 9 months
2
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
3
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