Precision Screening for Breast Cancer Risk

(RISC Trial)

Overseen By Greg Wolff

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Precision Health Equity Initiative

Disqualifiers: Breast cancer, Diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how personalized screening and care can improve health outcomes for women at risk of breast cancer, heart disease, and metabolic conditions like diabetes. By focusing on individual risk factors, the study aims to increase early detection and encourage healthier choices, potentially reducing healthcare costs. It will begin by examining women who are either currently undergoing screening or have been diagnosed with these conditions. Women diagnosed with or seeking screening for breast cancer, diabetes, or heart disease might find this trial suitable. As a Phase 2 trial, this research measures the effectiveness of the personalized care approach in an initial, smaller group, offering participants a chance to contribute to groundbreaking health improvements.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these risk-informed screening and care approaches are safe?

Research shows that using personalized information to determine who needs health screenings is still under investigation for safety in people. These methods aim to improve patient care by focusing on individual risk levels. Although detailed safety data from human studies is limited, similar approaches have informed decisions in other fields, such as environmental safety.

In healthcare, these methods enhance patient safety by targeting those most likely to benefit. While specific evidence about side effects in people is not yet available, the approach is likely well-tolerated. Ongoing studies aim to gather more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Risk-Informed Screening and Care Approaches because these methods aim to tailor screening and care based on individual risk factors, which could lead to more personalized and effective healthcare. Unlike traditional screening methods that take a one-size-fits-all approach, this strategy considers personal risk elements to potentially catch conditions earlier and reduce unnecessary procedures. This could mean more efficient use of resources and better outcomes for patients by focusing attention where it's most needed.

What evidence suggests that Risk-Informed Screening and Care Approaches might be effective for cancer, cardiovascular, and metabolic health?

Research shows that risk-informed screening can balance the benefits and drawbacks of cancer screening by using information about a person's disease risk to customize the approach. This method targets individuals who would benefit most from screening, potentially improving early detection and reducing unnecessary procedures. By focusing on personalized care, it may address disparities in healthcare access and support healthier choices. Studies have shown that using clinical data to rank risk effectively manages care and can lead to better health outcomes. The goal is to empower individuals to take charge of their health, possibly preventing or reversing some chronic conditions and lowering healthcare costs. ^{6 7 8 9 10}

Who Is on the Research Team?

Rakesh Patel, MD

Principal Investigator

Precision Health Equity Initiative

Are You a Good Fit for This Trial?

Inclusion Criteria

I was assigned female at birth.

I am a woman who has never had breast cancer, diabetes, or heart disease.

I am a woman diagnosed with breast cancer, diabetes, or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Risk Assessment

Participants undergo multi-disease personalized risk assessments and receive care plans

3 months

1 visit (in-person), ongoing virtual monitoring

Follow-up

Participants are monitored for changes in health measures such as blood pressure, BMI, and HDL levels

6 months

Regular virtual check-ins

Long-term Follow-up

Long-term monitoring of cancer health outcomes and patient compliance with recommendations

1-5 years

What Are the Treatments Tested in This Trial?

Interventions

• Risk-Informed Screening and Care Approaches

Who Is Running the Clinical Trial?

Precision Health Equity Initiative

Lead Sponsor

Trials

1

Recruited

10,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11106520/

Implementation considerations for risk-tailored cancer ...

Risk-tailored screening has emerged as a promising approach to optimise the balance of benefits and harms of existing population cancer ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05848856

Study Details | NCT05848856 | The RISC Registry--Risk ...

The RISC Registry seeks to pursue the intersection of breast cancer, metabolic, and cardiovascular risk in women and study the application of individualized ...

3.

kpwashingtonresearch.org

kpwashingtonresearch.org/index.php/our-research/research-areas/social-determinants/sonnet/sonnet-newsletter/sonnet-newsletter-spring-2022/how-health-systems-can-advance-social-risk-informed-care

How health systems can advance social risk-informed care

A new SONNET report provides comprehensive recommendations to help KP and other health systems tailor care in the context of patients' social risks.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0895435623002627

The design of studies testing the effectiveness of risk ...

We searched five online databases for studies evaluating the effect of risk-guided care among adults on clinical outcomes, process, or cost. Pairs of reviewers ...

5.

oncpracticemanagement.com

oncpracticemanagement.com/issues/2017/january-2017-vol-7-no-1/using-clinical-data-for-risk-stratification-an-effective-tool-for-care-management

Using Clinical Data for Risk Stratification: An Effective Tool ...

The best risk assessment tools are easily verifiable and consist of 5 to 10 questions per tool that cover the physical, functional, cognitive, environmental, ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK43454/

Risk Assessment: Evaluating Risks to Human Health and Safety

Risk assessment is a powerful tool that provides a rational framework for designing and managing an OHSP at institutions that use nonhuman primates.

7.

epa.gov

epa.gov/risk/conducting-human-health-risk-assessment

Conducting a Human Health Risk Assessment

This page provides the step-by-step instructions to how the EPA conducts a human health risk assessment with additional links to models, ...

8.

fda.gov

fda.gov/drugs/news-events-human-drugs/statistical-considerations-premarketing-risk-assessment-05162024

Statistical Considerations for Premarketing Risk Assessment

Address statistical considerations in the analysis of safety data, primarily adverse event data. Analysis of adverse outcomes is not a simple ...

9.

nrc.gov

nrc.gov/docs/ML2326/ML23268A331.pdf

Pele PRA Report Final - clean (Risk-Informed Methodology)

The PRA development process used standard methods acceptable to both DOE and NRC for assessing the safety of nuclear facilities. The process is summarized ...

10.

appliedclinicaltrialsonline.com

appliedclinicaltrialsonline.com/view/risk-based-monitoring-key-protecting-data-integrity-and-improving-patient-safety

Risk-Based Monitoring Key to Protecting Data Integrity and ...

Risk-Based Monitoring Key to Protecting Data Integrity and Improving Patient Safety. How does one determine and define the "risk" in a risk ...