The RISC Registry--Risk Informed Screening Registry

Part of paid clinical trials in Palo Alto, California.

Sponsor
Precision Health Equity Initiative
Study ID
NCT05848856
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Risk
  • Cardiometabolic Risk
  • Cardiovascular Disease Risk
  • Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Jul 2024
Primary completion
Sep 1, 2034
Completion
Sep 1, 2035

Study Design

Enrollment
10,000 participants (estimated)

Primary Outcome Measure

Disease risks and issues identified during multi-condition risk assessment [ Time Frame: Within 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PHEI--Precision Health Equity InitiativePalo AltoCalifornia94301
Mary Kay Hardwick
[email protected]
510-682-6256
Greg Wolff
[email protected]
650-744-3744
Rakesh Patel, MD (PRINCIPAL_INVESTIGATOR)

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