The RISC Registry: Understanding Risk-Informed Screening for Chronic Diseases

This study, called The RISC Registry, is looking at how different ways of screening for chronic diseases like breast cancer, heart disease (cardiovascular disease), and diabetes can help people. It's an observational study, meaning researchers will collect health information to understand how these screening methods affect doctor recommendations and whether patients follow through with them. The goal is to learn how to best identify disease risks and improve health outcomes. You might be able to join if you are a woman, aged 18 to 100, who has not been diagnosed with breast cancer, diabetes, or cardiovascular disease, or if you have been diagnosed with one of these conditions, or are coming in for screening.

Study design
This is an observational study aiming to enroll 10,000 women. It is designed to collect health information over time.
What's involved
The study will measure disease risks within 3 months and objective health measures like blood pressure and BMI within 6 months. It involves screening and follow-up related to breast cancer, cardiometabolic, and cardiovascular risks.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes within 3 months and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05848856

The RISC Registry--Risk Informed Screening Registry

Not Yet Recruiting
Not specifiedAges 18+Observational
Precision Health Equity Initiative
~10,000 participants
Updated 2024-07-11 on ClinicalTrials.gov
What's tested:Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease risks and issues identified during multi-condition risk assessment
Measured over Within 3 months
+11 more outcomes measured
Breast Cancer Risk
Cardiovascular Disease Risk
Cardiometabolic Risk
Diabetes
1 sites across 1 states
California1
  • Rakesh Patel, MD · PRINCIPAL_INVESTIGATOR · Precision Health Equity Initiative

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Eligibility criteria

Inclusion

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
  • Disease risks and issues identified during multi-condition risk assessmentWithin 3 months

    Types of disease risks or issues identified by implementing a multi-condition risk assessment in a single patient.

  • Objective health measures within different population subgroups--blood pressureWithin 6 months

    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.

  • Objective health measures within different population subgroups--BMIWithin 6 months

    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.

  • Objective health measures within different population subgroups--HDL levelsWithin 6 months

    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.

  • Objective health measures within different population subgroups-- abnormal germline genetic test resultsWithin 6 months

    Prevalence of abnormal germline genetic test results for cardiovascular and breast cancer disease risk, by different population sub groups

  • Number of subjects with newly diagnosed early stage cardiometabolic conditions and breast cancerWithin 6 months

    Early detection as measured by stage/extent of disease, linked to different risk assessments, care plans and patient engagement techniques, within different population subgroups.

  • Cancer health outcomes--imaging follow upWithin 1 year

    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

  • Short and Long term cancer health outcomes--biospecimen testsWithin 1 year

    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.

  • Short and Long term cancer health outcomes--biospecimen testsWithin 1 year

    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.

  • PRO--Patient Reported Outcomes: Percent of time patient screening behaviors changed based on recommendations made by shared decision making with the clinicianWithin 3 months

    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/)

  • PRO--Patient Reported Outcomes: compliance with post screening recommendationsWithin 3 months

    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/)

  • Clinician--Recommendations based on multi-condition risk assessmentsWithin 1 month

    Types of recommendations and percent (%) of time they change based on precision risk assessments