The RISC Registry--Risk Informed Screening Registry

Breast Cancer Risk Clinical Trial

— RISC  

Official title:

The Risk Informed Screening Registry (The RISC Registry)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05848856
• Other study ID #: RISC 1.0
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2033

Study information

• Verified date: May 2023
• Source: Precision Health Equity Initiative
• Contact: Mary Kay Hardwick, MBA
• Phone: 5106826256
• Email: mk[@]phei.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Health inequities are defined as systemic differences in the health status of different population groups. It is well established that there are many sources of health inequity in oncology including differences in mortality, cancer screening uptake, time to diagnosis and disparities in access to treatment and care.

Routine cancer screening and effective surveillance and follow up are some of the most effective ways to reduce the burden of cancer across an individual's lifetime and at the population level. While there is a lack of screening tests for many cancers, breast cancer, the second highest leading cause of cancer death in women, has a plethora of validated screening and risk reduction approaches which can yield earlier detection and effective ways of treating and following women at risk and with breast cancer and improve outcomes.

However, there is uneven adoption and inconsistent use of these technologies and care practices.

The RISC Registry is an observational study that seeks to understand the application of risk-informed screening and care approaches and pursue the hypothesis that these screening approaches accompanied by population appropriate methods of clinician and patient engagement may increase understanding and compliance with screening, surveillance and follow up recommendations by empowering people to make healthier choices, and support addressing disparities in screening and patient care.

The primary focus is cancer screening with a focus on 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 breast cancer risk.

Description:

The RISC Registry (the "Registry" ) is a longitudinal observational database designed to capture health information to help develop individualized disease risk and care plans in varied 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 personalized risk assessments and care plans at no charge to reduce cost as a barrier to screening.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: June 1, 2033
• Est. primary completion date: June 1, 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Female (Sex assigned at birth)

• Unaffected women--have never had breast cancer

• Females who have been diagnosed with breast cancer

• Females who are presenting for cancer screening

• 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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Breast Cancer Risk

Intervention

Behavioral:
• Cancer Risk Screening and Follow up
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

Locations

Country	Name	City	State
United States	PHEI--Precision Health Equity Initiative	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Precision Health Equity Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician: Types of clinical management recommendations made based on the risk assessment and care plan options	Types of recommendations may include mammography or other types of imaging, frequency of imaging, other types of tests to assess risk	Within 1 month
Primary	Clinician: % of time clinician recommendations were made and/or changed based on the different risk model information presented	Changes to recommendations based on new risk informed assessments	Within 1 month
Primary	PRO--Patient Reported Outcomes: % of time patient screening behaviors changed based on recommendations made by shared decision making with the clinician	Patient behavior correlated with recommendations evaluated by type of method of engagement and various social determinants of health.	Within 3 months