Clinical trial NCT05848856: The RISC Registry--Risk Informed Screening Registry
Official title: The Risk Informed Screening Registry (The RISC Registry)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Risk
Cardiovascular Disease Risk
Cardiometabolic Risk
Diabetes
Keywords: Breast cancer
Diabetes
Obesity
Coronary artery disease
Risk
Prevention
Genetics
Social drivers of health
Personal risk adjusted screening plans
Lead sponsor: Precision Health Equity Initiative
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusive study of women who are seeking screening for breast cancer, cardiovascular disease and cardiometabolic risk

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.

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

Primary outcomes:
measure: Disease risks and issues identified during multi-condition risk assessment
timeFrame: Within 3 months
measure: Objective health measures within different population subgroups--blood pressure
timeFrame: Within 6 months
measure: Objective health measures within different population subgroups--BMI
timeFrame: Within 6 months
measure: Objective health measures within different population subgroups--HDL levels
timeFrame: Within 6 months
measure: Objective health measures within different population subgroups-- abnormal germline genetic test results
timeFrame: Within 6 months
measure: Number of subjects with newly diagnosed early stage cardiometabolic conditions and breast cancer
timeFrame: Within 6 months
measure: Cancer health outcomes--imaging follow up
timeFrame: Within 1 year
measure: Short and Long term cancer health outcomes--biospecimen tests
timeFrame: Within 1 year
measure: Short and Long term cancer health outcomes--biospecimen tests
timeFrame: Within 1 year
measure: PRO--Patient Reported Outcomes: Percent of time patient screening behaviors changed based on recommendations made by shared decision making with the clinician
timeFrame: Within 3 months
measure: PRO--Patient Reported Outcomes: compliance with post screening recommendations
timeFrame: Within 3 months
measure: Clinician--Recommendations based on multi-condition risk assessments
timeFrame: Within 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: PHEI--Precision Health Equity Initiative
state: California
Study officials:
affiliation: Precision Health Equity Initiative
name: Rakesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: