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NCT05848856Not yet recruiting

The RISC Registry--Risk Informed Screening Registry

The Risk Informed Screening Registry (The RISC Registry)

Source: ClinicalTrials.gov · Last updated 11 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
28 Apr 2023
Start date
1 Sept 2024
Primary completion date
1 Sept 2034
Lead sponsor
Precision Health Equity Initiative
NCT number
NCT05848856

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 1 Sept 2024 to the primary completion date, 1 Sept 2034
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
PHEI--Precision Health Equity Initiative
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.