The RISC Registry--Risk Informed Screening Registry

NCT ID: NCT05848856

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2035-09-01

Brief 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.

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.

Conditions

Breast Cancer Risk; Cardiovascular Disease Risk; Cardiometabolic Risk; Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Precision Health Equity Initiative

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rakesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Precision Health Equity Initiative

Locations

PHEI--Precision Health Equity Initiative

Palo Alto, California, United States

Countries

United States

Central Contacts

Mary Kay Hardwick, MBA

Role: CONTACT

mk@phei.org

5106826256

Greg Wolff

Role: CONTACT

greg@phei.org

Facility Contacts

Mary Kay Hardwick

Role: primary

mk@phei.org

510-682-6256

Greg Wolff

Role: backup

greg@phei.org

650-744-3744

Other Identifiers

RISC 1.01

Identifier Type: -

Identifier Source: org_study_id