Breast Cancer RiskRISCNCT05848856
The RISC Registry--Risk Informed Screening Registry
An observational study of Breast Cancer Risk and Cardiovascular Disease Risk, run by Precision Health Equity Initiative at 1 site in United States.
Trial summary
Chronic diseases such as heart disease, cancer, and diabetes are the leading causes of death and disability in the United States. Six in ten adults have one chronic disease; 4 in 10 have two or more. These are also leading drivers of the nation's $4.1 trillion in annual health care costs. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Risk, Cardiovascular Disease Risk, Cardiometabolic Risk
- What is being tested?
- Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Sep 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusive study of women who are seeking screening for breast cancer, cardiovascular disease and cardiometabolic risk
Who may be able to join
- Female (Gender assigned at birth)
- Unaffected women (by breast cancer, diabetes or cardiovascular disease)
- Females who have been diagnosed with breast cancer, diabetes or cardiovascular disease
- Females who are presenting for cancer, metabolic health or cardiovascular screening
- Females presenting for mammography or other breast cancer screening procedures
- Females presenting for cholesterol, other blood tests aimed at metabolic and cardiovascular health screening, ECG's, EKG's or other noninvasive scans for the presence of or risk of heart disease
Show all 11Show fewer
- Ages 18+
- Willing to sign a study consent form
- Willing to participate in PRO surveys
- Willing to use technology to participate in the study procedures, if and as needed
- Pregnant women may be included
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greg Wolff contact
United States1 site
PHEI--Precision Health Equity Initiative
Palo Alto, California, 94301
Mary Kay Hardwick, 510-682-6256, mk@phei.org
Greg Wolff, 650-744-3744, greg@phei.org
About this study
Official title: The Risk Informed Screening Registry (The RISC Registry)
Chronic diseases such as heart disease, cancer, and diabetes are the leading causes of death and disability in the United States. Six in ten adults have one chronic disease; 4 in 10 have two or more. These are also leading drivers of the nation's $4.1 trillion in annual health care costs.
Cardiovascular disease is the number one cause of death for men and women, cancer is the second largest, with breast cancer being the second largest cause of death in women. Diabetes is the 8th highest cause of death for both men and women.
Read more
Routine screening, a focus on prevention, early detection, and patient engagement with proposed care plans, effective surveillance and follow up are some of the most effective ways to reduce the burden of chronic diseases across an individual's lifetime and at the population level.
Estimating dollar costs associated with non-compliance with screening and health management recommendations is complex and variable depending on the specific context, disease, and condition. But there is much evidence to indicate that a significant amount of these annual costs can be mitigated if compliance with health management recommendations increases, and health problems are prevented or detected early.
Access to screening and noncompliance with health management recommendations impact the entire population, but more disparities exist in racial and ethnic minorities and in the historically underserved for cancer, obesity, diabetes and cardiovascular disease.
The overall cost of these disparities in the U.S. has been estimated at around 1.24 trillion U.S. Dollars.
The RISC Registry seeks to pursue the intersection of breast cancer, metabolic, and cardiovascular risk in women and study the application of individualized multi-condition risk assessments, risk-informed or personalized screening, prevention and follow up care approaches in a broad cross section of patients. It pursues the hypothesis that these approaches accompanied by population appropriate methods of clinician and patient engagement may increase understanding and compliance with breast cancer, obesity, and metabolic/cardiovascular/cardiometabolic risk screening, surveillance and follow up recommendations by empowering women to make healthier choices.
In doing so, these methods may identify ways to address disparities in screening and patient care and ultimately promote early detection or even reversal of adverse health conditions, improve overall personal health, and reduce overall health care costs.
The primary focus is cancer, cardiovascular and metabolic health screening with a focus on utilization of Precision Screening. (Precision Screening attempts to separate those who will benefit from screening from those that may not, through use of information on disease risk.)
The study will start by focusing on women and risk for these diseases and health conditions.
Read the detailed description
The RISC Registry (the "Registry") is a longitudinal observational database designed to capture health information that inform individualized disease risk and care plans in varied and diverse patient populations and study how that information impacts physician recommendations and patient compliance.
The Registry was designed by a board of Scientific Advisors who are active users of risk assessment tools, and risk-informed screening protocols, including physicians, nurses, and patient advocates. Technology professionals and site administrators were also consulted regarding optimizing the process of data collection and dissemination. The Registry uses widely accepted standards for risk and disease classifications, results, management, and validated quality-of-life measures.
The Registry is vendor-agnostic and product-agnostic. This study will make a special effort to reach women who have historically been underserved by recruiting patients broadly distributed across different socioeconomic groups, ethnicities and diverse geographic areas.
The RISC Registry will help determine the ongoing value of Precision Screening in different clinical patient populations, shape guidelines for screening and optimal patient management, and support improvements in Precision Health and Precision Medicine support technology.
Eligible subjects will be offered multi-disease personalized risk assessments and care plans at no charge to reduce cost as a barrier to screening.
- Being tested
- Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up
- Keywords
- Breast cancer, Diabetes, Obesity, Coronary artery disease, Risk, Prevention, Genetics, Social drivers of health, Personal risk adjusted screening plans
- Medical subject headings
- Diabetes Mellitus, Breast Neoplasms, Obesity, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow upBehavioural
Study of different types of risk-informed screening approaches and the measurement of patient compliance with screening recommendations based on different approaches to patient engagement
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease risks and issues identified during multi-condition risk assessment
Types of disease risks or issues identified by implementing a multi-condition risk assessment in a single patient.
Measured: Within 3 months
Objective health measures within different population subgroups--blood pressure
Changes in an individual's blood pressure (both systolic and diastolic) tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups. Could include data gathered from connected health devices used as part of the care plan and follow up.
Measured: Within 6 months
Objective health measures within different population subgroups--BMI
Changes in an individual's BMI using combined height and weight measures, tracked over time, associated with different cardiovascular and breast cancer risk assessments, recommended care plans and patient engagement techniques, by different population subgroups.
Measured: Within 6 months
Objective health measures within different population subgroups--HDL levels
Changes (increase or decrease) in an individual's HDL tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups.
Measured: Within 6 months
Objective health measures within different population subgroups-- abnormal germline genetic test results
Prevalence of abnormal germline genetic test results for cardiovascular and breast cancer disease risk, by different population sub groups
Measured: Within 6 months
Number of subjects with newly diagnosed early stage cardiometabolic conditions and breast cancer
Early detection as measured by stage/extent of disease, linked to different risk assessments, care plans and patient engagement techniques, within different population subgroups.
Measured: Within 6 months
Cancer health outcomes--imaging follow up
Short term cancer health outcomes using RECIST (Response Evaluation Criteria in Solid Tumors) to analyse how well treatment has worked as measured or detected by imaging results
Measured: Within 1 year
Short and Long term cancer health outcomes--biospecimen tests
Short--within one year and longer term --within 5 years--cancer health outcomes using survival measure scales including Progression Free Survival (PFS) correlated with biospecimen tests that detect presence of disease.
Measured: Within 1 year
Short and Long term cancer health outcomes--biospecimen tests
Short--within one year and longer term --within 5 years--cancer health outcomes using survival measure scales including Event Free Survival (EFS--complications and events the treatment was supposed to prevent) correlated with biospecimen tests that detect presence of disease.
Measured: Within 1 year
PRO--Patient Reported Outcomes: Percent of time patient screening behaviors changed based on recommendations made by shared decision making with the clinician
Patient behavior correlated with recommendations evaluated by type of method of engagement and various social drivers of health (SDOH) using the PRAPARE survey (https://prapare.org/the-prapare-screening-tool/)
Measured: Within 3 months
PRO--Patient Reported Outcomes: compliance with post screening recommendations
Patient compliance with recommendations evaluated by type of method of engagement and various social drivers of health (SDOH) as measured by using the PRAPARE survey (https://prapare.org/the-prapare-screening-tool/)
Measured: Within 3 months
Clinician--Recommendations based on multi-condition risk assessments
Types of recommendations and percent (%) of time they change based on precision risk assessments
Measured: Within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2034 (estimated)
- Study completion1 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RiskStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Health Equity Initiative
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rakesh Patel, MD, Principal investigator, Precision Health Equity Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848856
- Sponsor's protocol ID
- RISC 1.01
- Acronym
- RISC
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If PHEI does share participant data it will be after review by the PHEI Scientific Advisory Committee and all data will be de-indentified.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk Informed Screening Registry (The RISC Registry)
- ClinicalTrials.gov ID
- NCT05848856
- Acronym / sponsor ID
- RISC / RISC 1.01
- Keywords
- Breast cancer, Diabetes, Obesity, Coronary artery disease, Risk, Prevention, Genetics, Social drivers of health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Precision Health Equity InitiativeUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2034 (estimated)
- Study completion
- 1 Sep 2035 (estimated)
- First posted
- 8 May 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.
Chronic diseases such as heart disease, cancer, and diabetes are the leading causes of death and disability in the United States. Six in ten adults have one chronic disease; 4 in 10 have two or more. These are also leading drivers of the nation's $4.1 trillion in annual health care costs.
Cardiovascular disease is the number one cause of death for men and women, cancer is the second largest, with breast cancer being the second largest cause of death in women. Diabetes is the 8th highest cause of death for both men and women.
Routine screening, a focus on prevention, early detection, and patient engagement with proposed care plans, effective surveillance and follow up are some of the most effective ways to reduce the burden of chronic diseases across an individual's lifetime and at the population level.
Estimating dollar costs associated with non-compliance with screening and health management recommendations is complex and variable depending on the specific context, disease, and condition. But there is much evidence to indicate that a significant amount of these annual costs can be mitigated if compliance with health management recommendations increases, and health problems are prevented or detected early.
Access to screening and noncompliance with health management recommendations impact the entire population, but more disparities exist in racial and ethnic minorities and in the historically underserved for cancer, obesity, diabetes and cardiovascular disease.
The overall cost of these disparities in the U.S. has been estimated at around 1.24 trillion U.S. Dollars.
The RISC Registry seeks to pursue the intersection of breast cancer, metabolic, and cardiovascular risk in women and study the application of individualized multi-condition risk assessments, risk-informed or personalized screening, prevention and follow up care approaches in a broad cross section of patients. It pursues the hypothesis that these approaches accompanied by population appropriate methods of clinician and patient engagement may increase understanding and compliance with breast cancer, obesity, and metabolic/cardiovascular/cardiometabolic risk screening, surveillance and follow up recommendations by empowering women to make healthier choices.
In doing so, these methods may identify ways to address disparities in screening and patient care and ultimately promote early detection or even reversal of adverse health conditions, improve overall personal health, and reduce overall health care costs.
The primary focus is cancer, cardiovascular and metabolic health screening with a focus on utilization of Precision Screening. (Precision Screening attempts to separate those who will benefit from screening from those that may not, through use of information on disease risk.)
The study will start by focusing on women and risk for these diseases and health conditions.
Detailed description
The RISC Registry (the "Registry") is a longitudinal observational database designed to capture health information that inform individualized disease risk and care plans in varied and diverse patient populations and study how that information impacts physician recommendations and patient compliance.
The Registry was designed by a board of Scientific Advisors who are active users of risk assessment tools, and risk-informed screening protocols, including physicians, nurses, and patient advocates. Technology professionals and site administrators were also consulted regarding optimizing the process of data collection and dissemination. The Registry uses widely accepted standards for risk and disease classifications, results, management, and validated quality-of-life measures.
The Registry is vendor-agnostic and product-agnostic. This study will make a special effort to reach women who have historically been underserved by recruiting patients broadly distributed across different socioeconomic groups, ethnicities and diverse geographic areas.
The RISC Registry will help determine the ongoing value of Precision Screening in different clinical patient populations, shape guidelines for screening and optimal patient management, and support improvements in Precision Health and Precision Medicine support technology.
Eligible subjects will be offered multi-disease personalized risk assessments and care plans at no charge to reduce cost as a barrier to screening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusive study of women who are seeking screening for breast cancer, cardiovascular disease and cardiometabolic risk
Key inclusion criteria (11 listed)
- Female (Gender assigned at birth)
- Unaffected women (by breast cancer, diabetes or cardiovascular disease)
- Females who have been diagnosed with breast cancer, diabetes or cardiovascular disease
- Females who are presenting for cancer, metabolic health or cardiovascular screening
- Females presenting for mammography or other breast cancer screening procedures
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 |
|---|---|---|
| Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow upStudy of different types of risk-informed screening approaches and the measurement of patient compliance with screening recommendations based on different approaches to patient engagement | Behavioural | – |
Primary outcome
Disease risks and issues identified during multi-condition risk assessment
Time frame: Within 3 months
Types of disease risks or issues identified by implementing a multi-condition risk assessment in a single patient.
Objective health measures within different population subgroups--blood pressure
Time frame: Within 6 months
Changes in an individual's blood pressure (both systolic and diastolic) tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups. Could include data gathered from connected health devices used as part of the care plan and follow up.
Objective health measures within different population subgroups--BMI
Time frame: Within 6 months
Changes in an individual's BMI using combined height and weight measures, tracked over time, associated with different cardiovascular and breast cancer risk assessments, recommended care plans and patient engagement techniques, by different population subgroups.
Objective health measures within different population subgroups--HDL levels
Time frame: Within 6 months
Changes (increase or decrease) in an individual's HDL tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups.
Objective health measures within different population subgroups-- abnormal germline genetic test results
Time frame: Within 6 months
Prevalence of abnormal germline genetic test results for cardiovascular and breast cancer disease risk, by different population sub groups
Number of subjects with newly diagnosed early stage cardiometabolic conditions and breast cancer
Time frame: Within 6 months
Early detection as measured by stage/extent of disease, linked to different risk assessments, care plans and patient engagement techniques, within different population subgroups.
Cancer health outcomes--imaging follow up
Time frame: Within 1 year
Short term cancer health outcomes using RECIST (Response Evaluation Criteria in Solid Tumors) to analyse how well treatment has worked as measured or detected by imaging results
Short and Long term cancer health outcomes--biospecimen tests
Time frame: Within 1 year
Short--within one year and longer term --within 5 years--cancer health outcomes using survival measure scales including Progression Free Survival (PFS) correlated with biospecimen tests that detect presence of disease.
Short and Long term cancer health outcomes--biospecimen tests
Time frame: Within 1 year
Short--within one year and longer term --within 5 years--cancer health outcomes using survival measure scales including Event Free Survival (EFS--complications and events the treatment was supposed to prevent) correlated with biospecimen tests that detect presence of disease.
PRO--Patient Reported Outcomes: Percent of time patient screening behaviors changed based on recommendations made by shared decision making with the clinician
Time frame: Within 3 months
Patient behavior correlated with recommendations evaluated by type of method of engagement and various social drivers of health (SDOH) using the PRAPARE survey (https://prapare.org/the-prapare-screening-tool/)
PRO--Patient Reported Outcomes: compliance with post screening recommendations
Time frame: Within 3 months
Patient compliance with recommendations evaluated by type of method of engagement and various social drivers of health (SDOH) as measured by using the PRAPARE survey (https://prapare.org/the-prapare-screening-tool/)
Clinician--Recommendations based on multi-condition risk assessments
Time frame: Within 1 month
Types of recommendations and percent (%) of time they change based on precision risk assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided. If PHEI does share participant data it will be after review by the PHEI Scientific Advisory Committee and all data will be de-indentified.
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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.
Greg Wolff contact
Rakesh Patel, MD principal investigator
Precision Health Equity Initiative
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 Cancer Risk and Cardiovascular Disease Risk, run by Precision Health Equity Initiative 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 11 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: opening soon, as of the sponsor's last update on 11 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Kay Hardwick, MBA (5106826256, mk@phei.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease risks and issues identified during multi-condition risk assessment (time frame: Within 3 months). The study lists 12 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 11 Jul 2024.