Breast CarcinomaNCT03804255
Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting
An observational study of Breast Carcinoma and Colorectal Carcinoma, run by ECOG-ACRIN Cancer Research Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Colorectal Carcinoma, Community Practice
- What is being tested?
- Survey Administration
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 29 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Onsite pathology practices within NCORP components and subcomponents that provide services to adult oncology groups
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Business Models in Healthcare
Chicago, Illinois, 60625
About this study
Official title: Biomarker Testing in Common Solid Cancers: An Assessment of Current Practices in Precision Oncology in the Community Setting
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Carcinoma, Colorectal Carcinoma, Community Practice, Lung Carcinoma, Melanoma, Solid Neoplasm
- Being tested
- Survey Administration
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey) | Participants complete a self-administered web-based Biomarker Survey and may also complete an Outcome Validation Survey. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Will determine whether each pathology practice is using genotyping or broad molecular profiling / next-generation tumor sequencing through self reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.
Measured: Up to 9 months
Use of MMR protein expression testing by immunohistochemistry (IHC) or microsatellite instability (MSI) in colorectal cancer
For colorectal cancer, will determine whether each pathology practice is using MMR protein expression testing by IHC or MSI through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals testing in this manner will be calculated.
Measured: Up to 9 months
Capacity to test for cMET or PTEN in lung cancer
Will determine whether each pathology practice has the capacity to test for cMET or PTEN through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.
Measured: Up to 9 months
Capacity to test for HRAS, AKT1, PTEN or PIK3CA in colorectal cancer
For colorectal cancer, will determine whether each pathology practice has the capacity to test for HRAS, AKT1, PTEN or PIK3CA through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals with the capacity will be calculated.
Measured: Up to 9 months
Reason for testing novel biomarkers (used for clinical care, clinical trials, or both)
For novel biomarkers, will determine whether each pathology practice tests for novel biomarkers to be used for clinical care, clinical trials, or both through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each time point will be calculated.
Measured: Up to 9 months
Number of days between sample availability and report availability for all biomarkers tested
Each pathology practice will report the number of days until all biomarkers tested are completed. The average number of days across all pathology practices and 95% two-sided confidence intervals will be calculated.
Measured: Up to 9 months
Proportion of pathology practices testing for novel biomarkers using a standard reflexive testing protocol
Will determine whether each pathology practice tests for novel biomarkers using a standard reflexive testing protocol through self-reported behavior. The proportion of pathology practices and exact 95% two-sided confidence intervals for each characteristic will be calculated.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start8 Jan 2019
- Primary completion29 May 2020
- Study completion29 May 2020
Why it stopped: Study closed before patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julia Trosman, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804255
- Sponsor's protocol ID
- EAQ161CD
- Other IDs
- NCI-2018-01707, EAQ161CD, ECOG-ACRIN-EAQ161CD, EAQ161CD, UG1CA189828
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2019
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Testing in Common Solid Cancers: An Assessment of Current Practices in Precision Oncology in the Community Setting
- ClinicalTrials.gov ID
- NCT03804255
- Acronym / sponsor ID
- EAQ161CD
- Conditions
- Breast Carcinoma, Colorectal Carcinoma, Community Practice, Lung Carcinoma, Melanoma, Solid Neoplasm
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study closed before patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey) | – | Other: Survey AdministrationParticipants complete a self-administered web-based Biomarker Survey and may also complete an Outcome Validation Survey. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Onsite pathology practices within NCORP components and subcomponents that provide services to adult oncology groups
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete surveys | Other | Observational (survey) |
Primary outcome
Presence of reflexive testing protocols for guideline-recommended biomarkers
Time frame: Up to 9 months
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.
Average turnaround time of no more than 10 business days for combined EGFR and ALK results reporting in lung cancer
Time frame: Up to 9 months
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.
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
Time frame: Up to 9 months
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.
7 secondary outcomes
Use of genotyping or broad molecular profiling/next generation tumor sequencing for EGFR and ALK testing in lung cancer
Time frame: Up to 9 months
Use of MMR protein expression testing by immunohistochemistry (IHC) or microsatellite instability (MSI) in colorectal cancer
Time frame: Up to 9 months
Capacity to test for cMET or PTEN in lung cancer
Time frame: Up to 9 months
Capacity to test for HRAS, AKT1, PTEN or PIK3CA in colorectal cancer
Time frame: Up to 9 months
Reason for testing novel biomarkers (used for clinical care, clinical trials, or both)
Time frame: Up to 9 months
Number of days between sample availability and report availability for all biomarkers tested
Time frame: Up to 9 months
Proportion of pathology practices testing for novel biomarkers using a standard reflexive testing protocol
Time frame: Up to 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Trosman principal investigator
ECOG-ACRIN Cancer Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Colorectal Carcinoma, run by ECOG-ACRIN Cancer Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of reflexive testing protocols for guideline-recommended biomarkers (time frame: Up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.