The RISC Registry--Risk Informed Screening Registry (RISC)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Cardiometabolic Risk; Cardiovascular Disease Risk; Breast Cancer Risk
• Intervention / Treatment: Behavioral: Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Mary Kay Hardwick, MBA; Phone Number: 5106826256; Email: mk@phei.org
• Study Contact Backup: Name: Greg Wolff; Email: greg@phei.org

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • PHEI--Precision Health Equity Initiative
      • Contact: Mary Kay Hardwick; Phone Number: 510-682-6256; Email: mk@phei.org
      • Contact: Greg Wolff; Phone Number: 650-744-3744; Email: greg@phei.org
      • Principal Investigator: Rakesh Patel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Inclusive study of women who are seeking screening for breast cancer, cardiovascular disease and cardiometabolic risk

Description

Inclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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.	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	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.	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.	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/)	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/)	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	Within 1 month

Collaborators and Investigators

• Sponsor: Precision Health Equity Initiative
• Investigators: Principal Investigator: Rakesh Patel, MD, Precision Health Equity Initiative

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): September 1, 2035

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Genetics; Diabetes; Obesity; Coronary artery disease; Breast cancer; Prevention; Risk; Social drivers of health; Personal risk adjusted screening plans
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: RISC 1.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If PHEI does share participant data it will be after review by the PHEI Scientific Advisory Committee and all data will be de-indentified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No