- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804255
Assessment of Current Biomarker Testing Practices for Common Solid Cancers in Precision Oncology in the Community Setting
Biomarker Testing in Common Solid Cancers: An Assessment of Current Practices in Precision Oncology in the Community Setting
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60625
- Center for Business Models in Healthcare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (survey)
Participants complete a self-administered web-based Biomarker Survey and may also complete an Outcome Validation Survey.
|
Complete surveys
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 9 months
|
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.
|
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
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.
|
Up to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
Up to 9 months
|
Capacity to test for cMET or PTEN in lung cancer
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
Capacity to test for HRAS, AKT1, PTEN or PIK3CA in colorectal cancer
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
Reason for testing novel biomarkers (used for clinical care, clinical trials, or both)
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
Number of days between sample availability and report availability for all biomarkers tested
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
Proportion of pathology practices testing for novel biomarkers using a standard reflexive testing protocol
Time Frame: Up to 9 months
|
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.
|
Up to 9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia Trosman, ECOG-ACRIN Cancer Research Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Breast Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Breast Neoplasms
- Carcinoma
- Colorectal Neoplasms
Other Study ID Numbers
- EAQ161CD (Other Identifier: CTEP)
- UG1CA189828 (U.S. NIH Grant/Contract)
- NCI-2018-01707 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- ECOG-ACRIN-EAQ161CD (Other Identifier: DCP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on Survey Administration
-
Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
-
Boston UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 InfectionUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMalignant Vascular NeoplasmUnited States
-
M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingMelanoma | COVID-19 InfectionUnited States
-
University of Rochester NCORP Research BaseNational Cancer Institute (NCI)WithdrawnCommunity Practice | StaffUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnSoft Tissue Sarcoma | Lymph Node CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingBladder CarcinomaUnited States