Advanced CancerNCT06090513
Molecular Services and EMR-Lab Integration Application (ELIA) for Reducing Healthcare Disparities in Cancer Patients
An observational study of Advanced Cancer and Solid Tumor, Adult, run by Bien-Willner Physicians Group PA at 1 site in United States.
Trial summary
The goal of this observational study is to measure and try to reduce leakage in precision medicine care in the community cancer clinic. The goal of precision medicine is to identify the best possible therapy the the patient based on the biology of the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Solid Tumor, Adult, Myeloid Malignancy
- What is being tested?
- Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation and limited genetic testing or no testing
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 18 Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All comers at a community cancer outpatient clinic or hospital
Who may be able to join
- newly diagnosed or change in status Advanced Cancer patient (recurrent, refractory, metastatic, or high grade)
- Cancer patient for whom genomic testing (comprehensive genomic profile (CGP)) is recommended by relevant guidelines
Who cannot join
- Patient does not seek additional treatment
- Patient younger than 18 years
- Treatment provided at a tertiary medical center
- CGP testing already performed and there is no change in patient cancer status
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
Niyati Nathwani, MD, 803-329-7772, nanathwani@cbcca.net
About this study
Official title: Molecular Services and EMR-Laboratory Integration Application (ELIA) for Reducing Leakage and Improving Healthcare Disparities in Cancer Patients
The goal of this observational study is to measure and try to reduce leakage in precision medicine care in the community cancer clinic. The goal of precision medicine is to identify the best possible therapy the the patient based on the biology of the tumor. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). It has been observed that there are healthcare disparities in the community setting compared to academic medical centers, particularly in the use of precision medicine. The main questions the study aims to answer are:
- How much leakage occurs in the use of precision medicine in the community setting?
- Can we reduce leakage by providing access to better tools and services typically found in the academic medical centers? Participants will not be directly impacted and will receive standard of care. Measurements will be made of how often physicians select the appropriate test for patients, and how often they select the most appropriate therapy for their patients before and after the implementation of tools created to reduce leakage.
We hope to reduce leakage in with the use of advanced tools and services, and use this study as a model to improve healthcare in the community cancer setting.
Read the detailed description
Precision Medicine in oncology requires the application of molecular diagnostic reporting to inform clinical decision making. However, its implementation has been slow and inefficient. Recent studies have demonstrated that contrary to new established standards of care and guidelines, eligible patients are often not getting the appropriate testing and test results are not being used appropriately to identify optimal therapies. This is especially true in the community oncology setting, resulting in healthcare disparities.
The investigators believe that the lack of efficiency and adoption of precision medicine is caused by "leakage" in the process of deploying genomic testing and reporting. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). Evidence suggests that leakage occurs at many steps of the process, and it is much more common in the community setting. A great deal of leakage occurs in the handling of ordering, retrieving, and tracking of external testing for necessary molecular diagnostic tests, the lack of integration between ordering facility and the laboratory, and a lack of expertise with understanding the complex reports.
This study aims to supply a community oncology practice with expertise, best-in-class testing, and integrative solutions to try to reduce leakage and reduce care disparities between the community clinic and large academic cancer centers.
This study will include a retrospective component, where the investigators will measure leakage (a predefined series of metrics)at a community cancer center over a six month period.
The investigators will then deploy a series of tools and services, including:
- Molecular Genetic Pathology expertise for tumor boards and case support
- Access to a best-in-class molecular test (TSO500)
- A software solution to improve data access between the clinic and lab (EMR-Lab Integration Application, ELIA) that was especially designed to reduce leakage in the community cancer care setting.
These services will be implemented for at least one year. The investigators will then remeasure the metrics over a year and see if there is a decrease in leakage.
It is expected that the deployment of expertise, improved testing, and improved data access and communication will reduce leakage and lead to improved patient care and outcomes. It is hoped that this will serve as a model to decrease healthcare disparities in cancer patients in the community setting.
- Conditions
- Advanced Cancer, Solid Tumor, Adult, Myeloid Malignancy
- Being tested
- Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation, limited genetic testing or no testing
- Keywords
- Comprehensive genomic profile, molecular genetic pathology, community cancer center, healthcare disparities, precision medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultationCombination product
TSO500; detect single nucleotide variants (SNV), INDELs, copy number alterations (CNAs), microsatellite instability (MSI), and tumor mutation burden (TMB) in eligible patients; ELIA software to interface clinic EMR to lab; Consultations and molecular tumor boards by molecular genetic pathologist (MGP)
limited genetic testing or no testingDiagnostic test
Minimal genetic testing for eligible patients or treatment without testing
| Study group | Role | What they receive |
|---|---|---|
| Control/Standard | Standard patient group: advanced cancer patients receiving limited and acceptable care without access to advanced genetic testing tools or expertise; patients at facility prior to deployment of TSO500, ELIA, and molecular tumor boards. Receives: Diagnostic Test: limited genetic testing or no testing | |
| Test group | Same patient population at the same facility after deployment of TSO500, ELIA, and molecular tumor board support. Receives: Combination Product: Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible patients getting the correct genetic test-informed treatment
Demonstration that deployment of SOC services and ELIA improves % of eligible patients placed on appropriate targeted therapies according to guidelines
Measured: 2 years
Service turn-around-time
Demonstration that standard-of-care services and ELIA improves turnaround times for getting actionable results, allowing physicians to make timely decisions.
Measured: 2 years
Secondary outcomes (6)
Number of patients with reports with actionable results
defined as 1: FDA-approved targeted therapy on indication; 2- recommendation on non-FDA approved indication
Measured: 2 years
Number of patients with reports placed on clinical trial
Measured: 2 years
Number of patients that get molecular genetic consults beyond the test interpretation
Measured: 2 years
Percent of patients getting targeted therapies
percentage of patients getting the correct targeted treatment identified by testing
Measured: 2 years
Percent of eligible patients getting genomic testing
Measured: 2 years
Percent of eligible patients getting the correct test based on guidelines
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start18 Oct 2024 (estimated)
- Primary completion18 Oct 2025 (estimated)
- Study completion18 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bien-Willner Physicians Group PA
- Sponsor type
- University, hospital or other
- Collaborators
- No One Left Alone, Carolina Blood and Cancer Care Associates
- Responsible party
- Sponsor
- Investigators
- Gabriel A Bien-Willner, MD, PhD, Principal investigator, Bien-Willner Physicians Grp PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090513
- Sponsor's protocol ID
- 2230817
- Status last verified
- Aug 2024
- First submitted
- 13 Oct 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Services and EMR-Laboratory Integration Application (ELIA) for Reducing Leakage and Improving Healthcare Disparities in Cancer Patients
- ClinicalTrials.gov ID
- NCT06090513
- Acronym / sponsor ID
- 2230817
- Conditions
- Advanced Cancer, Solid Tumor, Adult, Myeloid Malignancy
- Keywords
- Comprehensive genomic profile, molecular genetic pathology, community cancer center, healthcare disparities, precision medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bien-Willner Physicians Group PAUniversity, hospital or other
- Collaborators
- No One Left Alone, Carolina Blood and Cancer Care Associates
- Study start
- 18 Oct 2024 (estimated)
- Primary completion
- 18 Oct 2025 (estimated)
- Study completion
- 18 Oct 2026 (estimated)
- First posted
- 19 Oct 2023 (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.
The goal of this observational study is to measure and try to reduce leakage in precision medicine care in the community cancer clinic. The goal of precision medicine is to identify the best possible therapy the the patient based on the biology of the tumor. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). It has been observed that there are healthcare disparities in the community setting compared to academic medical centers, particularly in the use of precision medicine. The main questions the study aims to answer are:
- How much leakage occurs in the use of precision medicine in the community setting?
- Can we reduce leakage by providing access to better tools and services typically found in the academic medical centers? Participants will not be directly impacted and will receive standard of care. Measurements will be made of how often physicians select the appropriate test for patients, and how often they select the most appropriate therapy for their patients before and after the implementation of tools created to reduce leakage.
We hope to reduce leakage in with the use of advanced tools and services, and use this study as a model to improve healthcare in the community cancer setting.
Detailed description
Precision Medicine in oncology requires the application of molecular diagnostic reporting to inform clinical decision making. However, its implementation has been slow and inefficient. Recent studies have demonstrated that contrary to new established standards of care and guidelines, eligible patients are often not getting the appropriate testing and test results are not being used appropriately to identify optimal therapies. This is especially true in the community oncology setting, resulting in healthcare disparities.
The investigators believe that the lack of efficiency and adoption of precision medicine is caused by "leakage" in the process of deploying genomic testing and reporting. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). Evidence suggests that leakage occurs at many steps of the process, and it is much more common in the community setting. A great deal of leakage occurs in the handling of ordering, retrieving, and tracking of external testing for necessary molecular diagnostic tests, the lack of integration between ordering facility and the laboratory, and a lack of expertise with understanding the complex reports.
This study aims to supply a community oncology practice with expertise, best-in-class testing, and integrative solutions to try to reduce leakage and reduce care disparities between the community clinic and large academic cancer centers.
This study will include a retrospective component, where the investigators will measure leakage (a predefined series of metrics)at a community cancer center over a six month period.
The investigators will then deploy a series of tools and services, including:
- Molecular Genetic Pathology expertise for tumor boards and case support
- Access to a best-in-class molecular test (TSO500)
- A software solution to improve data access between the clinic and lab (EMR-Lab Integration Application, ELIA) that was especially designed to reduce leakage in the community cancer care setting.
These services will be implemented for at least one year. The investigators will then remeasure the metrics over a year and see if there is a decrease in leakage.
It is expected that the deployment of expertise, improved testing, and improved data access and communication will reduce leakage and lead to improved patient care and outcomes. It is hoped that this will serve as a model to decrease healthcare disparities in cancer patients in the community setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control/Standard | – | Diagnostic Test: limited genetic testing or no testingStandard patient group: advanced cancer patients receiving limited and acceptable care without access to advanced genetic testing tools or expertise; patients at facility prior to deployment of TSO500, ELIA, and molecular tumor boards. |
| Test group | – | Combination Product: Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultationSame patient population at the same facility after deployment of TSO500, ELIA, and molecular tumor board support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers at a community cancer outpatient clinic or hospital
Key inclusion criteria (2 listed)
- newly diagnosed or change in status Advanced Cancer patient (recurrent, refractory, metastatic, or high grade)
- Cancer patient for whom genomic testing (comprehensive genomic profile (CGP)) is recommended by relevant guidelines
Key exclusion criteria (4 listed)
- Patient does not seek additional treatment
- Patient younger than 18 years
- Treatment provided at a tertiary medical center
- CGP testing already performed and there is no change in patient cancer status
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 |
|---|---|---|
| Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultationTSO500; detect single nucleotide variants (SNV), INDELs, copy number alterations (CNAs), microsatellite instability (MSI), and tumor mutation burden (TMB) in eligible patients; ELIA software to interface clinic EMR to lab; Consultations and molecular tumor boards by molecular genetic pathologist (MGP) | Combination product | Test group |
| limited genetic testing or no testingMinimal genetic testing for eligible patients or treatment without testing | Diagnostic test | Control/Standard |
Primary outcome
Percentage of eligible patients getting the correct genetic test-informed treatment
Time frame: 2 years
Demonstration that deployment of SOC services and ELIA improves % of eligible patients placed on appropriate targeted therapies according to guidelines
Service turn-around-time
Time frame: 2 years
Demonstration that standard-of-care services and ELIA improves turnaround times for getting actionable results, allowing physicians to make timely decisions.
6 secondary outcomes
Number of patients with reports with actionable results
Time frame: 2 years
Number of patients with reports placed on clinical trial
Time frame: 2 years
Number of patients that get molecular genetic consults beyond the test interpretation
Time frame: 2 years
Percent of patients getting targeted therapies
Time frame: 2 years
Percent of eligible patients getting genomic testing
Time frame: 2 years
Percent of eligible patients getting the correct test based on guidelines
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Gabriel A Bien-Willner, MD, PhD principal investigator
Bien-Willner Physicians Grp PA
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 Advanced Cancer and Solid Tumor, Adult, run by Bien-Willner Physicians Group PA 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haydee Diaz, MBASCP (3468310189, haydee@bwpgprecisionmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible patients getting the correct genetic test-informed treatment (time frame: 2 years). The study lists 2 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 6 Aug 2024.